sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 2 ]

80

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Losartan 100 mg Tablets arm 2: Cozaar® 100 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 100 mg Tablets intervention 2: 100 mg Tablets

intervention 1: Losartan intervention 2: Cozaar®

1

Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139

0

NCT01124175

[ 5 ]

188

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.

null

Rhinitis, Allergic, Seasonal Asthma

Seasonal Allergic Rhinitis Asthma

null

2

arm 1: Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks arm 2: Matching placebo nasal spray, administered QD for 4 weeks

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril. intervention 2: Matching placebo nasal spray, administered QD as 2 sprays in each nostril. intervention 3: Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.

intervention 1: Mometasone intervention 2: Placebo intervention 3: Albuterol/Salbutamol

0

null

0

NCT00070707

[ 3 ]

206

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

null

Multiple Sclerosis

Walking Ability Muscle strength Spasticity

null

4

arm 1: Placebo control, twice a day (b.i.d.) arm 2: 10 milligram (mg) fampridine b.i.d. arm 3: 15 mg fampridine b.i.d. arm 4: 20 mg fampridine b.i.d.

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo for 15 weeks intervention 2: 2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg) intervention 3: 10 mg twice daily for 1 week 15 mg twice daily for 14 weeks 2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (15 mg) 1 week down titration (10 mg) intervention 4: 2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (20 mg) 1 week down titration (15 mg x 3 days, 10 mg x 4 days)

intervention 1: Placebo intervention 2: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) intervention 3: 15 mg fampridine-SR (4-aminopyridine, 4-AP) intervention 4: 20 mg fampridine-SR (4-aminopyridine, 4-AP)

25

0

NCT00053417

[ 0 ]

572

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

1FEMALE

false

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

null

Vulvovaginal Candidiasis

Vulvovaginal Candidiasis Terconazole

null

2

arm 1: Terconazole Vaginal Suppository arm 2: Terazol Vaginal Suppository

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days intervention 2: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

intervention 1: Terconazole Vaginal Suppository intervention 2: Terazol Vaginal Suppository

0

null

0

NCT00803738

[ 2 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.

Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.

Epilepsy

Epilepsy Oxcarbazepine Eslicarbazepine Acetate BIA 2-093

null

3

arm 1: BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid arm 2: BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od arm 3: oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: BIA 2-093 intervention 2: Oxcarbazepine

1

S. Mamede Do Coronado | Trofa | Portugal | N/A | N/A

0

NCT01679002

[ 3 ]

905

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.

null

Cardiovascular Diseases Heart Diseases

null

4

arm 1: Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days arm 2: Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days arm 3: Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days arm 4: Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

[ 0, 0, 0, 1 ]

2

[ 0, 0 ]

intervention 1: Administered orally intervention 2: Administered orally

intervention 1: Prasugrel (CS-747) intervention 2: Clopidogrel

2

0

NCT00059215

[ 3 ]

169

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.

null

Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections

null

2

arm 1: None arm 2: cSSSI - complicated skin and skin structure infections

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days intervention 2: Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.

intervention 1: Telavancin intervention 2: Vancomycin or antistaphylococcal penicillin

1

Chula Vista | California | United States | -117.0842 | 32.64005

0

NCT00061633

[ 3 ]

61

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.

Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.

Cervical Strain

Cervical strain whiplash ibuprofen cyclobenzaprine

null

3

arm 1: None arm 2: None arm 3: None

[ 1, 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 5 mg orally every 8 hours as needed intervention 2: Ibuprofen 400 mg every 8 hours as needed intervention 3: Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

intervention 1: Cyclobenzaprine intervention 2: Ibuprofen intervention 3: Ibuprofen plus Cyclobenzaprine

1

Stony Brook | New York | United States | -73.14094 | 40.92565

0

NCT00790270

[ 2 ]

244

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

null

Osteoporosis

null

4

arm 1: alendronate/vitamin D combination then alendronate arm 2: alendronate then alendronate/vitamin D combination arm 3: alendronate/vitamin D combination then vitamin D arm 4: vitamin D then alendronate/vitamin D combination

[ 0, 0, 0, 0 ]

3

[ 0, 0, 7 ]

intervention 1: A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. intervention 2: A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period. intervention 3: A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: alendronate intervention 3: Comparator: cholecalciferol (Vitamin D)

0

null

0

NCT00806416

[ 2 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

null

Chemotherapy-Induced Nausea and Vomiting

null

6

arm 1: Treatment Sequence A-B-C arm 2: Treatment Sequence B-C-A arm 3: Treatment Sequence C-A-B arm 4: Treatment Sequence A-C-B arm 5: Treatment Sequence B-A-C arm 6: Treatment Sequence C-B-A

[ 0, 0, 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) intervention 2: a single 8 mg tablet of Zofran marketed in the U.K., taken PO intervention 3: a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

intervention 1: Comparator: Treatment A (Zofran, ondansetron) intervention 2: Comparator: Treatment B (Zofran, ondansetron) intervention 3: Comparator: Treatment C (Zofran, ondansetron)

0

null

0

NCT00971633

[ 2 ]

50

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions with dosing by applesauce-sprinkle method.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Lansoprazole 30 mg Delayed-Release Capsule arm 2: Prevacid® 30 mg Delayed-Release Capsule

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 30 mg Delayed-Release Capsules intervention 2: 30 mg Delayed-Release Capsule

intervention 1: Lansoprazole intervention 2: Prevacid®

1

Saint Charles | Missouri | United States | -90.48123 | 38.78394

0

NCT01046253

[ 4 ]

204

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

null

Spinal Cord Injury Muscle Spasticity

spinal cord injury muscle spasticity

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 25mg bid (twice daily) intervention 2: Placebo

intervention 1: Fampridine-SR intervention 2: Placebo

30

1

NCT01683838

[ 3 ]

395

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Osteoarthritis, Knee

Primary Disease: Knee Primary Osteoarthritis

null

5

arm 1: Placebo tablet arm 2: 25 mg PG-530742 arm 3: 50 mg PG-530742 arm 4: 100 mg PG-530742 arm 5: 200 mg PG-530742

[ 2, 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: One 25 mg PG-530742 tablet, twice daily for for one year intervention 2: One placebo tablet, twice daily for for one year intervention 3: One 50 mg PG-530742 tablet, twice daily for for one year intervention 4: 100 mg PG-530742 tablet, twice a day for one year intervention 5: 200 mg PG-530742 tablet, twice a day for one year

intervention 1: PG-530742 intervention 2: Placebo intervention 3: 50 mg PG-530742 intervention 4: 100 mg PG-530742 intervention 5: 200 mg PG-530742

23

Visegrád | Gizella Telep | Hungary | 18.9709 | 47.78526 Győr | Hid Utica 2 | Hungary | 17.63512 | 47.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Ashford | Middlesex | United Kingdom | 0.87376 | 51.14648 Stanmore | Middlesex | United Kingdom | -0.31667 | 51.61667 London | Se17eh | United Kingdom | -0.12574 | 51.50853 Addlestone | Surrey | United Kingdom | -0.49353 | 51.37135 East Horsley | Surrey | United Kingdom | -0.43207 | 51.27358 Stratford-upon-Avon | Warwickshire | United Kingdom | -1.70734 | 52.19166 Crawley | West Sussex | United Kingdom | -0.18312 | 51.11303 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Edgbaston | N/A | United Kingdom | -1.92115 | 52.4623 Kent | N/A | United Kingdom | 0.52021 | 51.27893 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 London Bridge | N/A | United Kingdom | N/A | N/A Reading | N/A | United Kingdom | -0.97113 | 51.45625 Tonbridge | N/A | United Kingdom | 0.27363 | 51.19532 Wigan | N/A | United Kingdom | -2.63706 | 53.54296

0

NCT00041756

[ 4 ]

760

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Gout

uric Acid xanthine oxidase tophi Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Febuxostat 80 mg, orally, once daily for up to 52 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 52 weeks. intervention 3: Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol

0

null

0

NCT00102440

[ 2 ]

20

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets

intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Hyzaar®

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01149486

[ 3 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The primary objective of this study is to evaluate the safety and tolerability of 4 doses of lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an additional 3 dose levels over a 16-week period. The secondary objectives of this study included the evaluation of the pharmacodynamics of lomitapide based on: * Percent change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides, and very low density lipoprotein cholesterol (VLDL-C) concentrations at the end of each 4-week dosing period compared to the Baseline value of each parameter at the end of the previous dose phase(s). * Changes in other plasma lipoproteins: apolipoproteins (apo B, apo AI, apo AII, apo CIII, apo E) and lipoprotein a \[Lp(a)\].

This is a single center, open-label, Phase 2 clinical trial designed to evaluate the safety, tolerability, and pharmacodynamics of lomitapide in the treatment of patients with homozygous familial hypercholesterolemia (HoFH). Patients are required to stop all lipid-lowering therapies, including apheresis, within 4 weeks prior to the Baseline visit and throughout the study. Patients are placed on a rigorous low-fat diet (\<10% of energy from total dietary fat) at the Screening assessment; dietary counseling by a registered dietitian will be initiated at Screening and will continue at each subsequent study visit. Patients initially receive 0.03 mg/kg of lomitapide orally every day for 4 weeks. Intra-patient dose escalation to 0.1 mg/kg, 0.3 mg/kg/day and 1.0 mg/kg/day occur every 4 weeks if specific protocol-defined stopping rules related to Grade 3 or 4 toxicities or serious adverse events (SAEs) do not apply. The study includes 15 study visits over 22 weeks: a Screening visit (Visit 1) conducted within 2 weeks prior to dosing, a Baseline visit (Visit 2) conducted on Day 1 prior to the first dose, 12 visits conducted during the treatment period (Visits 3 through 14), and a Follow-up visit (Visit 15) conducted approximately 4 weeks after the last dose of lomitapide. Screening and Baseline procedures include medical and medication history, physical examination, vital signs, 12-lead electrocardiogram (ECG), pulmonary function tests (PFTs), safety laboratory tests, fat soluble vitamin levels and a fatty acid profile. Nuclear magnetic resonance spectroscopy (NMRS) of the liver will be conducted at Baseline, at the end of each dosing period, and at the follow up visit to assess hepatic fat content. Baseline efficacy assessment includes a fasting lipid profile (TC, LDL-C \[directly measured\], VLDL-C, high density lipoprotein-cholesterol \[HDL-C\], triglycerides, and apolipoproteins \[apo B, apo AI, apo AII, apo CIII, apo E\] and Lp(a)). Safety and lipid profile assessments are repeated during the treatment period and at the Follow-up visit conducted 28 days after the last dose of lomitapide.

Homozygous Familial Hypercholesterolemia

null

1

arm 1: This is an open label trial where all patients receive lomitapide (AEGR733/BMS-201038)at escalating doses

[ 0 ]

1

[ 0 ]

intervention 1: Oral administration with escalating doses administered once daily

intervention 1: Lomitapide

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT01556906

[ 3 ]

3

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for adults with meningioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with meningioma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with meningioma.

OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults with meningima as measured by an objective response to therapy (complete response, partial response) or stable disease. * To determine the safety and tolerance of Antineoplaston therapy in adults with meningima. OVERVIEW: This is a single arm, open-label study in which adults with meningioma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Meningioma

adult meningioma recurrent adult meningioma

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003483

[ 4 ]

39

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.

null

Mucopolysaccharidosis VI

null

2

arm 1: None arm 2: None

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Placebo intervention 2: N-acetylgalactosamine 4-sulfatase

1

Novato | California | United States | -122.5697 | 38.10742

0

NCT00067470

[ 4 ]

177

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.

This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).

Palliative Care Pain Cancer

null

3

arm 1: Placebo control arm 2: Active treatment arm 3: Active treatment

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours. intervention 2: Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours. intervention 3: Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

intervention 1: Placebo intervention 2: Sativex® intervention 3: THC Alone

1

Shrewsbury | N/A | United Kingdom | -2.75208 | 52.71009

0

NCT00674609

[ 2 ]

32

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (1 x 100 mg tablet), or a single oral dose of the reference formulation, Pletal® (1 x 100 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Therapeutic Equivalency

null

2

arm 1: A single dose of cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. arm 2: A single dose of cilostazol (Pletal® 1 x 100 mg tablet) administered after an overnight fast of at least 10 hours.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours intervention 2: Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.

intervention 1: Cilostazol 100 mg Tablets intervention 2: Cilostazol (Pletal®) 100 mg Tablets

0

null

0

NCT00684762

[ 4 ]

189

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.

This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal.

Spasticity Multiple Sclerosis

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

intervention 1: Sativex® intervention 2: Placebo

1

Reading | Oxfordshire | United Kingdom | -0.97113 | 51.45625

0

NCT00711646

[ 4 ]

125

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

This was a six week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex®. Subjects with peripheral neuropathic pain characterised by allodynia, were screened to determine eligibility and entered a seven day baseline period. Subjects then returned to the centre for randomisation and dose introduction, and received either placebo or Sativex in a double blind manner for five weeks, with a follow up visit 7 to 10 days after the end of the treatment period. The primary efficacy measure was the difference in pain severity at the end of treatment, measured using a peripheral neuropathic pain 0 to 10 numerical rating scale.

Pain Peripheral Neuropathy

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

intervention 1: Sativex® intervention 2: Placebo

1

Fazakerley | Liverpool | United Kingdom | -2.92863 | 53.4614

0

NCT00711880

[ 2 ]

27

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

true

0ALL

false

The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok Metropolis, Thailand, after single oral dose administration under fasting conditions. An additional purpose of this study is to evaluate the effect of food on the Mutual Pharmaceutical Company product.

The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok Metropolis, Thailand, after single oral dose administration under fasting conditions. An additional purpose of this study is to evaluate the effect of food on the Mutual Pharmaceutical Company product. Twenty-seven healthy, non-smoking, non-obese, male and female volunteers at least 18 years of age will be randomly assigned in crossover fashion to receive each of three dosing regimens in sequence with a 7 day washout period between dosing periods. In each of the three dosing periods, after a fast of at least 10 hours, subjects will receive one dose of one of the three test products (treatment A - quinine sulfate capsules 324 mg, treatment B - quinine sulphate tablets 300 mg, treatment C - quinine sulfate capsules 324 mg administered thirty minutes after the initiation of a standardized, high-fat breakfast). Subjects will fast for 4 hours after dosing. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of quinine sulfate under fed and fasting conditions and quinine sulphate under fasting conditions. Sitting blood pressure and heart rate will be obtained prior to dosing and at 1, 2, 4 and 12 hours post-dose and upon completion of the study. An electrocardiogram will be recorded at check-in and at 2, 4, 6, 12, and 24 hours post-dose. Subjects will be monitored throughout their participation in the study for adverse reactions.

Healthy

Bioavailability

null

3

arm 1: A single dose of quinine sulfate 324 mg administered with 240 mL of room temperature water after an overnight fast of at least 10 hours. arm 2: A single dose of quinine sulphate 300 mg administered with 240 mL of room temperature water after an overnight fast of at least 10 hours. arm 3: A single dose of quinine sulfate 324 mg administered with 240 mL of room temperature water thirty minutes after the initiation of a standardized, high-fat breakfast.

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: One 324 mg capsule administered after an overnight fast of at least 10 hours. intervention 2: One 300 mg tablet administered after an overnight fast of at least 10 hours. intervention 3: One 324 mg capsule administered thirty minutes after the initiation of a standardized, high-fat breakfast.

intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Quinine Sulphate Tablets 300 mg intervention 3: Quinine Sulfate Capsules 324 mg

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT00727272

[ 2 ]

26

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.

null

Pain

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1 Tramadol Contramid OAD 200 mg tablet as a single dose intervention 2: 1 Zytram 200 mg tablet as a single dose

intervention 1: Tramadol Contramid OAD intervention 2: Zytram

0

null

0

NCT00911742

[ 2 ]

24

NON_RANDOMIZED

PARALLEL

7BASIC_SCIENCE

0NONE

true

0ALL

false

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.

null

Renal Impairment

CP-690 550 pharmacokinetics renal impairment

null

4

arm 1: Healthy volunteers arm 2: patients with mild (\>50 and ≤80 mL/min) renal impairment arm 3: patients with moderate (≥30 and ≤50 mL/min) renal impairment arm 4: patients with severe (\<30 mL/min) renal impairment

[ 5, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 10 mg (2 x 5 mg tablets), single dose intervention 2: 10 mg (2 x 5 mg tablets), single dose intervention 3: 10 mg (2 x 5 mg tablets), single dose intervention 4: 10 mg (2 x 5 mg tablets), single dose

intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550

4

0

NCT01740362

[ 2 ]

18

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.

Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled. Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.

Epilepsy

null

3

arm 1: 1. st period - 16 mL oral suspension 50 mg/mL 2. nd period - Four 200 mg tablets 3. rd period - One 800 mg tablet arm 2: 1. st period - One 800 mg tablet 2. nd period - 16 mL oral suspension 50 mg/mL 3. rd period - Four 200 mg tablets arm 3: 1. st period - Four 200 mg tablets 2. nd period - One 800 mg tablet 3. rd period - 16 mL oral suspension 50 mg/mL

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: oral suspension 50 mg/mL intervention 2: 200 mg tablet intervention 3: 800 mg tablet

intervention 1: BIA 2-093 intervention 2: BIA 2-093 intervention 3: BIA 2-093

1

Azinhaga de Santa Comba - Celas | Coimbra District | Portugal | N/A | N/A

0

NCT02279667

[ 4 ]

1,987

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

null

Colorectal Cancer

null

2

arm 1: Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). arm 2: Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 425mg/m2 iv daily from day 1 to day 5 every 28 days. intervention 2: 20mg/m2 iv daily from day 1 to day 5 every 28 days. intervention 3: 1250mg/m2 po bid on days 1-14 every 21 days.

intervention 1: 5-Fluorouracil intervention 2: Leucovorin intervention 3: Capecitabine [Xeloda]

133

Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fountain Valley | California | United States | -117.95367 | 33.70918 Los Angeles | California | United States | -118.24368 | 34.05223 Hartford | Connecticut | United States | -72.68509 | 41.76371 Miami | Florida | United States | -80.19366 | 25.77427 Decatur | Georgia | United States | -84.29631 | 33.77483 Columbia | Missouri | United States | -92.33407 | 38.95171 St Louis | Missouri | United States | -90.19789 | 38.62727 Albany | New York | United States | -73.75623 | 42.65258 Buffalo | New York | United States | -78.87837 | 42.88645 Cleveland | Ohio | United States | -81.69541 | 41.4995 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Nashville | Tennessee | United States | -86.78444 | 36.16589 Austin | Texas | United States | -97.74306 | 30.26715 Tyler | Texas | United States | -95.30106 | 32.35126 Seattle | Washington | United States | -122.33207 | 47.60621 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Adelaide | N/A | Australia | 138.59863 | -34.92866 Bendigo | N/A | Australia | 144.28024 | -36.75818 Brisbane | N/A | Australia | 153.02809 | -27.46794 Fitzroy | N/A | Australia | 144.97833 | -37.79839 Kurralta Park | N/A | Australia | 138.56702 | -34.95142 Melbourne | N/A | Australia | 144.96332 | -37.814 Melbourne | N/A | Australia | 144.96332 | -37.814 Perth | N/A | Australia | 115.8614 | -31.95224 Port Macquarie | N/A | Australia | 152.90894 | -31.43084 St Leonards | N/A | Australia | 151.19836 | -33.82344 Sydney | N/A | Australia | 151.20732 | -33.86785 Wodonga | N/A | Australia | 146.88809 | -36.12179 Hall in Tirol | N/A | Austria | 11.51667 | 47.28333 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Klagenfurt | N/A | Austria | 14.30528 | 46.62472 Linz | N/A | Austria | 14.28611 | 48.30639 Oberwart | N/A | Austria | 16.20595 | 47.28971 Sankt Pölten | N/A | Austria | 15.63333 | 48.2 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Brussels | N/A | Belgium | 4.34878 | 50.85045 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Sorocaba | N/A | Brazil | -47.45806 | -23.50167 Calgary | Alberta | Canada | -114.08529 | 51.05011 Kelowna | British Columbia | Canada | -119.48568 | 49.88307 Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Montreal | Quebec | Canada | -73.58781 | 45.50884 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Berlin | N/A | Germany | 13.41053 | 52.52437 Braunschweig | N/A | Germany | 10.52673 | 52.26594 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Göttingen | N/A | Germany | 9.93228 | 51.53443 Grenzach-Wyhlen | N/A | Germany | 7.68333 | 47.55 Halle | N/A | Germany | 11.97947 | 51.48158 Hanover | N/A | Germany | 9.73322 | 52.37052 Kassel | N/A | Germany | 9.5 | 51.31667 Lehrte | N/A | Germany | 9.97919 | 52.37193 Magdeburg | N/A | Germany | 11.62916 | 52.12773 München | N/A | Germany | 13.31243 | 51.60698 Oldenburg | N/A | Germany | 8.21467 | 53.14118 Oldenburg | N/A | Germany | 8.21467 | 53.14118 Ravensburg | N/A | Germany | 9.61062 | 47.78198 Regensburg | N/A | Germany | 12.10161 | 49.01513 Villingen-Schwenningen | N/A | Germany | 8.49358 | 48.06226 Wuppertal | N/A | Germany | 7.14816 | 51.25627 Haifa | N/A | Israel | 34.99928 | 32.81303 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Aviano | N/A | Italy | 12.59472 | 46.07056 Bergamo | N/A | Italy | 9.66721 | 45.69601 Bologna | N/A | Italy | 11.33875 | 44.49381 Cuneo | N/A | Italy | 7.54828 | 44.39071 Genova | N/A | Italy | 11.87211 | 45.21604 Livorno | N/A | Italy | 10.32615 | 43.54427 Mantova | N/A | Italy | 10.79784 | 45.16031 Milan | N/A | Italy | 12.59836 | 42.78235 Mirano | N/A | Italy | 12.10775 | 45.49458 Modena | N/A | Italy | 10.92539 | 44.64783 Napoli | N/A | Italy | 14.5195 | 40.87618 Pisa | N/A | Italy | 10.4036 | 43.70853 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Terni | N/A | Italy | 12.64329 | 42.56335 Torino | N/A | Italy | 11.99138 | 44.88856 Torino | N/A | Italy | 11.99138 | 44.88856 Vecchiazzano | N/A | Italy | N/A | N/A Venezia | N/A | Italy | 11.17365 | 44.42329 Vicenza | N/A | Italy | 11.5475 | 45.54672 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Porto | N/A | Portugal | -8.61099 | 41.14961 Bilbao | N/A | Spain | -2.92528 | 43.26271 Córdoba | N/A | Spain | -4.77275 | 37.89155 El Palmar Murcia | N/A | Spain | N/A | N/A Elche | N/A | Spain | -0.70107 | 38.26218 Jaén | N/A | Spain | -3.79028 | 37.76922 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Navarra | N/A | Spain | N/A | N/A Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939 Valencia | N/A | Spain | -0.37966 | 39.47391 Basel | N/A | Switzerland | 7.57327 | 47.55839 Basel | N/A | Switzerland | 7.57327 | 47.55839 Bellinzona | N/A | Switzerland | 9.01703 | 46.19278 Bern | N/A | Switzerland | 7.44744 | 46.94809 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 Zurich | N/A | Switzerland | 8.55 | 47.36667 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Edinburgh | N/A | United Kingdom | -3.19648 | 55.95206 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Guildford | N/A | United Kingdom | -0.57427 | 51.23536 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 Luton | N/A | United Kingdom | -0.41748 | 51.87967 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 Northwood | N/A | United Kingdom | -0.42454 | 51.61162 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Salisbury | N/A | United Kingdom | -1.79569 | 51.06931 Southampton | N/A | United Kingdom | -1.40428 | 50.90395

0

NCT00009737

[ 4 ]

1,072

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout. Subjects will receive treatment for 28 weeks.

Gout

Uric Acid, gout, xanthine oxidase, febuxostat, tophi

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 0, 0, 0, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Febuxostat 80 mg, orally, once daily for up to 28 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 28 weeks. intervention 3: Febuxostat 240 mg, orally, once daily for up to 28 weeks. intervention 4: Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine \>1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily. intervention 5: Placebo, orally, once daily for up to 28 weeks.

intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat intervention 4: Allopurinol intervention 5: Placebo

0

null

0

NCT00174915

[ 2 ]

14

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.

null

Dyslipidemia

null

2

arm 1: Fenofibrate U.S. Formulation arm 2: Fenofibrate UK Formulation

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods. intervention 2: Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

intervention 1: fenofibrate (U.S. formulation) intervention 2: fenofibrate (UK formulation)

0

null

0

NCT00928694

[ 2 ]

80

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets

intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Losartan potassium/Hydrochlorothiazide

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01149473

[ 2 ]

59

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. This subject population was selected to evaluate potentially relevant biological activity of CP-690,550 as well as assessing safety and pharmacokinetics.

null

Psoriasis Immunomodulation

Psoriasis PASI plaques skin biopsy immunomodulation

null

6

arm 1: 5 mg BID for 13 days and once on Day 14 arm 2: 10 mg BID for13 days and once on Day 14\* arm 3: 20 mg BID for 13 days and once on Day 14 arm 4: 30 mg BID for 13 days and once on Day 14 arm 5: 60 mg QD for 14 days arm 6: 50 mg BID x 13 days and once on day 14

[ 0, 0, 0, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: 5 mg BID For 13 days and once on Day 14 intervention 2: 10 mg BID for 13 days and once on Day 14\* intervention 3: 20 mg BID for 13 days and once on Day 14 intervention 4: 30 mg BID for 13 days and once on Day 14 intervention 5: 60 mg tablet once a day (QD) for 14 days intervention 6: 50 mg tablets two times a day (BID) for 13 days and once on day 14

intervention 1: tofacitinib intervention 2: tofacitinib intervention 3: tofacitinib intervention 4: tofacitinib intervention 5: tofacitinib intervention 6: tofacitinib

1

Little Rock | Arkansas | United States | -92.28959 | 34.74648

0

NCT01736696

[ 3 ]

28

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

2MALE

false

Testosterone has traditionally been regarded as a risk factor for heart disease due to the fact that males have a higher incidence of this disease than women, at least until the menopause. However recent studies have shown that men with low levels of testosterone may be at an increased risk of developing coronary heart disease (furring up of the blood vessels supplying blood to the heart). Our group has demonstrated a relaxing effect of testosterone in isolated animal coronary arteries (blood vessels supplying blood to the heart). We have shown that short-term testosterone administration can increase coronary artery and brachial artery (blood vessel in the arm) blood flow and can decrease the lack of blood supply to the heart muscle in men with coronary artery disease. These findings indicate a need for similar but longer-term studies to investigate the possible beneficial effects of longer-term testosterone therapy on the heart and blood vessels. Should this treatment be shown to be beneficial to men with coronary artery disease it may be a useful additional therapy for men with the furring up of arteries in the heart and the resulting angina. Aim To investigate our hypothesis that testosterone can beneficially affect myocardial perfusion, vascular reactivity, metabolic risk factors for coronary heart disease and improve quality of life in men with low plasma testosterone levels and coronary heart disease.

The main purpose of this project is to determine whether testosterone treatment over a number of weeks can beneficially affect myocardial perfusion, vascular reactivity, metabolic risk factors and quality of life in men with documented coronary heart disease. Men with documented significant coronary artery disease and a positive exercise test for myocardial ischaemia will be enrolled into the study. They will be randomised to active testosterone therapy (5 mg/day) or placebo for 2 months. After 2 months they will undergo MRI perfusion scanning, radial artery applanation tonometry to assess endothelial function, blood sampling for analysis of metabolic risk factors for coronary heart disease, complete quality of life questionnaires and will cross-over to the opposite treatment. After a further 2 month period these tests will be repeated. Angina diaries will be kept for the duration of the study.

Coronary Heart Disease

null

2

arm 1: oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks arm 2: identical to active medication, taken in an identical way to the active arm

[ 0, 2 ]

1

[ 0 ]

intervention 1: Licensed for androgen deficiency

intervention 1: Testosterone undecanoate

1

London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00239590

[ 4 ]

213

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

null

Spinal Cord Injury Muscle Spasticity

spinal cord injury muscle spasticity

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 10 ]

intervention 1: 25mg bid (twice daily) intervention 2: Placebo

intervention 1: Fampridine-SR intervention 2: Placebo

45

0

NCT00041717

[ 4 ]

1,992

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.

null

Rhinitis, Allergic, Perennial

null

2

arm 1: Montelukast arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: one 10 mg tablet, taken once daily at bed time for 6 weeks intervention 2: one placebo tablet, taken once daily at bed time for 6 weeks

intervention 1: Montelukast intervention 2: Comparator: Placebo

0

null

0

NCT00092118

[ 2 ]

38

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.

The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions. Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Healthy Therapeutic Equivalency

null

2

arm 1: A single dose of zolpidem tartrate 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. arm 2: A single dose of Ambien® 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. intervention 2: 10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

intervention 1: Zolpidem Tartrate 10 mg tablet intervention 2: Zolpidem Tartrate 10 mg tablet (Ambien®)

0

null

0

NCT00658541

[ 2 ]

38

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.

The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions. Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Healthy

equivalency Therapeutic equivalency

null

2

arm 1: A single dose of zolpidem tartrate 10 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Ambien® 10 mg administered after an overnight fast of at least 10 hours.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 10 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 10 mg tablet administered after an overnight fast of at least 10 hours

intervention 1: Zolpidem Tartrate 10 mg tablet intervention 2: Zolpidem Tartrate 10 mg tablet (Ambien®)

0

null

0

NCT00684814

[ 3 ]

423

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

null

Type 2 Diabetes Mellitus

null

7

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

[ 0, 0, 0, 0, 0, 0, 2 ]

7

[ 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: Tablets, Oral, 2.5 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 5 mg, once daily, 12 weeks intervention 3: Tablets, Oral, 10 mg, once daily, 12 weeks intervention 4: Tablets, Oral, 20 mg, once daily, 12 weeks intervention 5: Tablets, Oral, 40 mg, once daily, 12 weeks intervention 6: Tablets, Oral, 100 mg, once daily, 6 weeks intervention 7: Tablets, Oral, 0 mg, once daily, 6 and 12 weeks

intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Saxagliptin intervention 6: Saxagliptin intervention 7: Placebo

0

null

0

NCT00950599

[ 4 ]

19

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.

Juvenile Rheumatoid Arthritis

Systemic Onset Juvenile Rheumatoid Arthritis SOJRA Fever Rash Joint Pain

null

4

arm 1: Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. arm 2: Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. arm 3: Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months. arm 4: Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment in Part 2.

[ 0, 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Administered by subcutaneous injection twice a week intervention 2: Administered by subcutaneous injection twice a week

intervention 1: Etanercept intervention 2: Placebo

0

null

0

NCT00078806

[ 3 ]

175

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.

null

Mild Cognitive Impairment

Mild Cognitive Impairment Memory Loss Alzheimer's Disease Brain Aging Ampalex® CX516

null

2

arm 1: CX516 - 900 mg arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: CX516 intervention 2: Placebo

8

0

NCT00040443

[ 4 ]

529

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Osteoarthritis

Chronic pain opioid transdermal osteoarthritis

null

2

arm 1: Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h) arm 2: Placebo to match BTDS 5, 10 or 20 mcg/h

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

intervention 1: Buprenorphine transdermal patch intervention 2: Placebo

44

0

NCT00313846

[ 3 ]

72

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF). The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one to one randomization. The study will measure how much of the activity of the enzyme elastase is inhibited by AAT.

The optimum deposition site (bronchial or peripheral) in CF patients for AAT will be investigated by measuring several parameters in induced sputum. The study will start with a 2 week run-in period in which the planned 60 patients inhale isotonic saline once daily. This period is followed by a 4 week treatment period where 30 patients inhale AAT for peripheral deposition and 30 patients inhale AAT for bronchial deposition. Six patients in each group will be asked to collect spontaneous sputum at home. Twenty-five milligrams of AAT will be deposited at one of the two target sites using the AKITA® device. The inhalation should take place in the evening between 18.00 and 23.00 h. Patients will inhale saline once daily for 2 weeks (run-in period) followed by 4 weeks of once daily inhalation of AAT. Induced sputum will be collected at visits to the clinic at the start of the run-in, at the start of AAT treatment, and at 2 and 4 weeks after the start of AAT treatment.

Cystic Fibrosis

null

2

arm 1: Bronchial Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks arm 2: Peripheral Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks

[ 0, 0 ]

1

[ 0 ]

intervention 1: 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks.

intervention 1: Alpha1-Proteinase Inhibitor (Human)

0

null

0

NCT00486837

[ 0 ]

10

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

2MALE

false

Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedation scores. Attempts to improve sedation monitoring through the use of the electroencephalogram(EEG) have been disappointing. Derived variables based on the unstimulated EEG fail to predict the response to external stimuli at the clinically most relevant light-to-moderate sedation levels, and the overlap between moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers during propofol sedation, independent of the concomitant administration of remifentanil. This approach has a potential clinical application for improved monitoring of sedation. Since the effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor sedation needs to be evaluated with different sedative drugs. Therefore we will administer two widely used drug combinations (dexmedetomidine/remifentanil and midazolam/remifentanil) in healthy volunteers and record ERPS and processed EEG during clinical relevant sedation levels

Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedation scores. Attempts to improve sedation monitoring through the use of the electroencephalogram (EEG) have been disappointing. Derived variables based on the unstimulated EEG fail to predict the response to external stimuli at the clinically most relevant light-to-moderate sedation levels, and the overlap between moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers during propofol sedation, independent of the concomitant administration of remifentanil. This approach has a potential clinical application for improved monitoring of sedation. Since the effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor sedation needs to be evaluated with different sedative drugs. The alpha-2 agonist dexmedetomidine (dex) has been approved for short-term sedation in surgical intensive care unit (ICU) patients. Preliminary data suggest that the risk of delirium may be substantially reduced when dexmedetomidine is used to produce sedation. Since dexmedetomidine acts via different receptors and brain areas than do benzodiazepines and propofol, its impact on the brain electrophysiology may also be different. The assessment of dexmedetomidine's effects on the EEG and ERPs at various sedation levels has been limited in humans. We hypothesized that the combinations DEXMEDETOMIDINE/REMIFANTANIL (dex/remi) and MIDAZOLAM/REMIFENTANIL (mida/remi) would induce the same changes in EEG and long-latency ERPs during light-to-moderate levels of sedation in healthy subjects, despite the different quality of sedation that they provide. The opioid remifentanil was added because virtually all patients in the ICU have some level of pain and receive an opioid analgesic in combination with a sedative. 10 healthy subjects were assessed with both drug combinations (dex/remi and mida/remi), at least 7 days apart. The sequence of the drug combinations were randomized.

Conscious Sedation Deep Sedation Critical Care

dexmedetomidine midazolam remifentanil Electroencephalography Event related potentials BIS Bispectral Index Response Entropy State Entropy

null

2

arm 1: Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week arm 2: Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week

[ 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Infusion of dexmedetomidine intervention 2: Midazolam infusion intervention 3: Infusion of remifentanil

intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Remifentanil

1

Bern | N/A | Switzerland | 7.44744 | 46.94809

0

NCT00641563

[ 2 ]

22

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions.

The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline® (primidone tablets) in adult subjects under fasting conditions. Twenty-two healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two primidone dosing regimens in sequence with a 14 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, primidone (1 x 50 mg tablet) or a single oral dose of the reference formulation, Mysoline® (1 x 50 mg tablet). After a 14 day washout period, on the morning of Day 15 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of primidone. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and at 3, 4, 6, 24 and 72 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Therapeutic Equivalency

null

2

arm 1: A single dose of primidone 50 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Mysoline® 50 mg administered after an overnight fast of at least 10 hours.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 50 mg tablet administered after an overnight fast of at least 10 hours. intervention 2: 50 mg tablet administered after an overnight fast of at least 10 hours.

intervention 1: Primidone 50 mg Tablet intervention 2: Primidone (Mysoline®) 50 mg Tablet

0

null

0

NCT00685165

[ 2 ]

24

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

1SINGLE

true

0ALL

false

The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.

The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions. Twenty-four healthy, non-smoking, non-obese, male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of treatment A, Quinine Sulfate 1 x 324 mg capsule, or a single oral dose of treatment B, Quinine Sulfate 2 x 324 mg capsules. After a 7 day washout period,on the morning of Day 8 following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Quinine Sulfate. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following each dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Healthy

Bioavailability

null

2

arm 1: Quinine Sulfate 1 x 324 mg capsule dose. arm 2: Quinine Sulfate 2 x 324 mg capsules dose.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 1 x 324 mg capsule intervention 2: 2 x 324 mg capsules

intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Quinine Sulfate Capsules 324 mg

0

null

0

NCT00726895

[ 5 ]

24

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

0NONE

false

1FEMALE

false

An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).

null

Contraception

null

3

arm 1: Microgynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE). arm 2: Evra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. arm 3: Nuvaring(R), Place the ring in the vagina for 21 days, remove for one week. Repeat with new Ring. Dose: per ring 11.7 mg ENG and 2.7 mg EE releasing a daily average amount of 0.120 mg ENG and 0.015 mg EE.

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. intervention 2: A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. intervention 3: NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.

intervention 1: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets intervention 2: norelgestrominum and ethinylestradiol patch oral contraceptive patch intervention 3: Nuvaring ™ (etonorgestrel/ethinylestradiol)

0

null

0

NCT01044056

[ 3 ]

45

RANDOMIZED

SEQUENTIAL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.

null

Idiopathic Thrombocytopenic Purpura

Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Thrombocytopenic Thrombocytopenia ITP

null

10

arm 1: Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 2: Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 3: Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. arm 4: Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 5: Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 6: Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 7: Participants received placebo subcutaneously once a week for 6 weeks. arm 8: Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks. arm 9: Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks. arm 10: Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.

[ 0, 0, 0, 0, 0, 0, 2, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

intervention 1: Romiplostim intervention 2: Placebo

0

null

0

NCT00111475

[ 3 ]

11

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for children with low grade astrocytomas that have not responded to standard therapy provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with low grade astrocytomas that have not responded to standard therapy PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with low grade astrocytomas that has not responded to standard therapy.

OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with low grade gliomas that has not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in children with a brain tumor. OVERVIEW: This is a single arm, open-label study in which children with low grade astrocytomas that have not responded to standard therapy receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Low Grade Astrocytomas

childhood low-grade astrocytoma recurrent childhood astrocytoma persistent childhood astrocytoma

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003468

[ 3 ]

129

null

0TREATMENT

0NONE

false

1FEMALE

null

The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy.

null

Ovarian Cancer

Advanced, refractory, or recurrent ovarian cancer

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Pertuzumab (rhuMAb 2C4)

0

null

0

NCT00058552

[ 3 ]

12

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.

null

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.

intervention 1: AG-013736 (Axitinib)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00071006

[ 4 ]

204

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Osteoarthritis

Osteoarthritis, opioid, transdermal

null

2

arm 1: Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4. arm 2: Initial doses (Level 1) of BTDS 20.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Buprenorphine transdermal patch applied for 7-day wear.

intervention 1: Buprenorphine transdermal patch

36

0

NCT00312572

[ 2 ]

54

RANDOMIZED

CROSSOVER

null

1SINGLE

true

2MALE

false

The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.

The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions. Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Lovastatin dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive a standardized high-fat, high-calorie meal 30 minutes before drug administration. Thirty minutes after the start of the breakfast, a single oral dose of either the test formulation, Lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, Mevacor® (1 x 40 mg tablet) will be administered. After a 7 day washout period, on the morning of Day 8, following an overnight fast of at least 10 hours and 30 minutes after the start of a standardized high-fat, high-calorie meal, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Lovastatin. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Vital signs will be monitored if judged necessary by the physician in charge. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Healthy

Therapeutic Equivalency

null

2

arm 1: A single dose of Lovastatin 40 mg administered under fed conditions. arm 2: A single dose of Lovastatin (Mevacor®) 40 mg administered under fed conditions.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast intervention 2: 40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast

intervention 1: Lovastatin 40 mg Tablets intervention 2: Lovastatin (Mevacor®) 40 mg Tablets

1

Montreal | Quebec | Canada | -73.58781 | 45.50884

0

NCT00684723

[ 2 ]

32

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (2 x 50 mg tablets), or a single oral dose of the reference formulation, Pletal® (2 x 50 mg tablets). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Therapeutic Equivalency, Healthy

null

2

arm 1: A single dose of cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours. arm 2: A single dose of Cilostazol (Pletal® tablets, 2 x 50 mg ) administered after an overnight fast of at least 10 hours.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours intervention 2: Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.

intervention 1: Cilostazol 50 mg Tablets intervention 2: Cilostazol (Pletal®) 50 mg Tablets

0

null

0

NCT00685802

[ 4 ]

20

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

0ALL

false

A single center pilot study to determine the protective effects of RhuMAB-E25 on airway physiology and biology in allergic asthmatics that undergo bronchoprovocation with methacholine. The primary study objective determines the protective impact of RhuMAB-E25 on airway inflammation as reflected in exhaled nitric oxide (NO) levels in allergic asthmatics. The secondary objective determines the protective effect of rhuMAB E25 against airway bronchoconstriction as reflected in the Provocative Concentration of methacholine to cause a 20% fall in FEV1(PC20) with methacholine challenge testing.

This is a single center prospective, open-label study. Eligible subjects will undergo two baseline measurements of exhaled Nitric Oxide (NO) before and after methacholine challenge testing at least one week apart. All subjects will receive treatment with RhuMAB-E25 in an open label fashion at day 0, weeks 4 and 8, and undergo methacholine challenge and NO measurement at screening/baseline, weeks 0, 6, and 12. Complete Blood Count (CBC) will be done at screening/baseline, weeks 1, 2, 4, 8, and week 12. For women of childbearing potential, a screening pregnancy test will be done. All statistical analysis will occur at the conclusion of this study.

Allergic Asthma

Asthma

null

0

null

1

[ 0 ]

intervention 1: three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.

intervention 1: RhuMab-E25

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00829179

[ 4 ]

392

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to collect information regarding the long-term (6 and 12 months) safety of Tramadol HCl Once-A-Day(OAD) 300 mg.

null

Osteoarthritis, Knee

Moderate to severe symptomatic osteoarthritis of the knee

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Tramadol Once A Day

0

null

0

NCT00833911

[ 2 ]

56

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Lansoprazole 30 mg delayed-release Capsules arm 2: Prevacid® 30 mg delayed-release Capsules

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 30 mg delayed-release Capsule intervention 2: 30 mg delayed-release Capsule

intervention 1: Lansoprazole intervention 2: Prevacid®

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01045967

[ 4 ]

290

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Osteoarthritis

Osteoarthritis Opioid Transdermal

null

1

arm 1: Buprenorphine transdermal patch

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear intervention 3: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch

42

0

NCT01141283

[ 2, 3 ]

16

NA

SEQUENTIAL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.

null

Thrombocytopenic Purpura

Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia

null

1

arm 1: Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.

[ 0 ]

1

[ 0 ]

intervention 1: Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.

intervention 1: Romiplostim

0

null

0

NCT00117143

[ 3 ]

174

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.

Anesthesia, General

null

24

arm 1: Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®. arm 2: Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 3: Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 4: Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 5: Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 6: Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 7: Placebo (single intravenous (IV) bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 8: Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 9: Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 10: Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 11: Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 12: Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 13: Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 14: Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 15: Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 16: Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 17: Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 18: Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 19: Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 20: Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 21: Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 22: Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 23: Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. arm 24: Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.

[ 2, 0, 0, 0, 0, 0, 2, 0, 0, 0, 0, 0, 2, 0, 0, 0, 0, 0, 2, 0, 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight. intervention 2: 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, intervention 3: Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

intervention 1: Sugammadex intervention 2: Placebo intervention 3: Esmeron®

0

null

0

NCT00535743

[ 5 ]

674

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

The purpose of this research study is to: 1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and 2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).

The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of smokers: those with genotypes associated with less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with higher levels of novelty-seeking, depression, and attention deficit symptoms.

Smoking

Nicotine nasal spray + counseling Transdermal nicotine + counseling

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks. intervention 2: 8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.

intervention 1: Nicoderm Transdermal Patch intervention 2: Nicotine Nasal Spray

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00326781

[ 2 ]

36

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.

null

Advanced Solid Tumors

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 0, 0, 0, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state intervention 2: Axitinib continuous oral dosing (20 mg twice a day) in the fed state intervention 3: Axitinib continuous oral dosing (5 mg twice a day) in the fed state intervention 4: Axitinib continuous oral dosing (15 mg once a day) in the fed state intervention 5: Axitinib continuous oral dosing (5 mg twice a day) in the fasted state intervention 6: Axitinib continuous oral dosing (2 mg twice a day on the first day of dosing, followed by 5 mg twice a day) in the fasted state

intervention 1: AG-013736 intervention 2: AG-013736 intervention 3: AG-013736 intervention 4: AG-013736 intervention 5: AG-013736 intervention 6: AG-013736

3

0

NCT01469052

[ 3 ]

201

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.

null

Infections, Gram-positive Bacterial

Abscess Burns Cellulitis Ulcer Wound infections

null

2

arm 1: None arm 2: cSSSI - comlicated skin and skin structure infections

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days intervention 2: Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.

intervention 1: Telavancin intervention 2: vancomycin or antistaphylococcal penicillin

1

National City | California | United States | -117.0992 | 32.67811

0

NCT00077675

[ 5 ]

89

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

null

Anemia, Iron-Deficiency Kidney Failure, Chronic

Iron deficiency Anemia Chronic kidney disease Sodium Ferric Gluconate Anemia, Iron-Deficiency/drug therapy/etiology Kidney Failure, Chronic/blood/complications/therapy

null

2

arm 1: Sodium ferric gluconate arm 2: ferrous sulfate

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks intervention 2: ferrous sulfate, 325 mg oral, three times daily for 6 weeks

intervention 1: Sodium Ferric Gluconate Complex in Sucrose Injection intervention 2: Ferrous sulfate tablets

24

0

NCT00224055

[ 2 ]

36

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions.

null

Healthy

null

2

arm 1: Test 1000 mg Tablet arm 2: Reference Listed Valacyclovir 1000 mg Tablet

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Test 1000 mg Tablet intervention 2: Reference Listed Valacyclovir 1000 mg Tablet

intervention 1: Valacyclovir intervention 2: Valacyclovir

1

Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139

0

NCT01149460

[ 4 ]

332

NON_RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.

All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg. Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension. All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory. Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (\~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).

Alcohol Dependence

null

2

arm 1: Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks. arm 2: IM injection administered once every 4 weeks for up to 48 weeks.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: naltrexone for extended-release injectable suspension intervention 2: naltrexone for extended-release injectable suspension

intervention 1: Medisorb naltrexone 190 mg intervention 2: Medisorb naltrexone 380 mg

0

null

0

NCT01218971

[ 3 ]

42

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

null

The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.

null

Prostate Cancer

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: rhuMAb 2C4 (pertuzumab)

0

null

0

NCT00058539

[ 4 ]

263

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

null

Obstructive Sleep Apnea Sleep Hypopnea

Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc Nuvigil

null

2

arm 1: Armodafinil 150 mg/day arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Armodafinil 150 mg once daily in the morning intervention 2: Matching placebo tablets once daily

intervention 1: Armodafinil 150 mg/day intervention 2: Placebo

0

null

0

NCT00079677

[ 4 ]

62

RANDOMIZED

CROSSOVER

1PREVENTION

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

null

Asthma, Exercise-Induced

null

2

arm 1: Montelukast - Placebo arm 2: Placebo - Montelukast

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge intervention 2: Placebo tablet administered orally as a single witnessed dose before exercise challenge

intervention 1: Comparator: Montelukast intervention 2: Comparator: Placebo

0

null

0

NCT00090142

[ 4 ]

121

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Anemia

iron peritoneal dialysis anemia

null

2

arm 1: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. arm 2: Stable erythropoietin (EPO) dose and no supplemental iron.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. intervention 2: Stable erythropoietin (EPO) dose and no supplemental iron.

intervention 1: Venofer and stable erythropoietin (EPO) regimen intervention 2: stable erythropoietin (EPO) regimen

0

null

0

NCT00236938

[ 4 ]

182

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Anemia

CKD iron anemia

null

2

arm 1: iron sucrose injection arm 2: oral iron

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. intervention 2: oral iron tablets; 325 mg three times a day orally for 56 days

intervention 1: Venofer intervention 2: Ferrous Sulfate

1

Valley Forge | Pennsylvania | United States | -76.70747 | 39.98454

0

NCT00236977

[ 2 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.

Migraine

Migraine, Prochlorperazine aerosol

null

6

arm 1: Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg arm 2: Inhaled Staccato prochlorperazine 1.25 mg arm 3: Inhaled Staccato prochlorperazine 2.5 mg arm 4: Inhaled Staccato prochlorperazine 5 mg arm 5: Inhaled Staccato prochlorperazine 10 mg arm 6: inhaled Staccato Placebo (0 mg)

[ 0, 0, 0, 0, 0, 2 ]

8

[ 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: IV Prochlorperazine for bioavailability intervention 2: Inhaled Staccato Prochlorperazine 0.625 mg intervention 3: Inhaled Staccato Prochlorperazine 1.25 mg intervention 4: Inhaled Staccato Prochlorperazine 2.5 mg intervention 5: InhaledStaccato Prochlorperazine 5 mg intervention 6: InhaledStaccato Prochlorperazine 10 mg intervention 7: Inhaled Staccato Placebo (0 mg) intervention 8: Prochlorperazine 10 mg IV over 5 sec for patient qualification

intervention 1: Prochlorperazine 0.5 mg IV over 5 sec intervention 2: Inhaled prochlorperazine 0.625 mg intervention 3: Inhaled prochlorperazine 1.25 mg intervention 4: Inhaled prochlorperazine 2.5 mg intervention 5: Inhaled prochlorperazine 5 mg intervention 6: Inhaled prochlorperazine 10 mg intervention 7: Inhaled placebo intervention 8: Prochlorperazine 10 mg IV over 5 sec

1

Austin | Texas | United States | -97.74306 | 30.26715

0

NCT00610727

[ 2 ]

54

RANDOMIZED

CROSSOVER

null

1SINGLE

true

2MALE

false

The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions.

The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions. Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two lovastatin dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, Mevacor® (1 x 40 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of lovastatin. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Vital signs will be monitored if judged necessary by the physician in charge. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Healthy

Therapeutic Equivalency

null

2

arm 1: A single dose of Lovastatin 40 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Lovastatin (Mevacor®) 40 mg administered after an overnight fast of at least 10 hours.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 40 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 40 mg tablet administered after an overnight fast of at least 10 hours

intervention 1: Lovastatin 40 mg tablets intervention 2: Lovastatin (Mevacor®) 40 mg Tablets

1

Montreal | N/A | Canada | -73.58781 | 45.50884

0

NCT00685685

[ 4 ]

324

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

null

Attention Deficit Disorder With Hyperactivity

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 0, 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

intervention 1: SPD503 (1 mg) intervention 2: SPD503 (2 mg) intervention 3: SPD503 (3 mg) intervention 4: SPD503 (4 mg) intervention 5: Placebo

0

null

0

NCT00150618

[ 4 ]

69

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses. Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization. Patients are followed for 12 months.

Meconium Aspiration

cardiovascular and respiratory diseases meconium aspiration syndrome rare disease

null

2

arm 1: Lucinactant via bronchoaveolar lavage arm 2: Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

[ 0, 5 ]

2

[ 0, 10 ]

intervention 1: Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other. intervention 2: The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC

intervention 1: Lucinactant intervention 2: Standard Care

1

Warrington | Pennsylvania | United States | -75.13406 | 40.24927

0

NCT00004500

[ 3 ]

65

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

null

Anemia

null

9

arm 1: Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 2: Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 3: Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 4: Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 5: Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 6: Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 7: Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 8: Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. arm 9: Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Differing doses and frequencies of sc administration

intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]

15

0

NCT00048048

[ 4 ]

231

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

null

Narcolepsy

Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy

null

4

arm 1: Xyrem + Modafinil Placebo arm 2: Xyrem Placebo + Modafinil Placebo arm 3: Xyrem Placebo + Modafinil at established dose arm 4: Xyrem + Modafinil at established dose

[ 0, 2, 1, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks. intervention 2: Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. intervention 3: Modafinil oral capsules at 200 to 600 mg per day for 8 weeks. intervention 4: Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.

intervention 1: Xyrem intervention 2: Xyrem Placebo intervention 3: Modafinil at established dose intervention 4: Modafinil (Placebo)

40

0

NCT00066170

[ 4 ]

395

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.

null

Obstructive Sleep Apnea Hypopnea

Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc NUVIGIL

null

3

arm 1: Armodafinil 250 mg/day arm 2: Armodafinil 150 mg/day arm 3: Placebo

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily in the morning

intervention 1: Armodafinil 250 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Placebo

0

null

0

NCT00078325

[ 4 ]

938

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

true

1FEMALE

false

This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

null

Prevention of Pregnancy

Contraception

null

2

arm 1: Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle arm 2: Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets intervention 2: One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

intervention 1: Norethindrone Acetate/Ethinyl Estradiol 24 Days intervention 2: Norethindrone Acetate /Ethinyl Estradiol 21 Days

34

0

NCT00932321

[ 2 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.

null

Type 2 Diabetes Mellitus

null

2

arm 1: Sitagliptin anhydrous formulation arm 2: Sitagliptin monohydrate FMI formulation

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods. intervention 2: Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.

intervention 1: Sitagliptin phosphate anhydrous formulation intervention 2: Comparator: sitagliptin phosphate monohydrate form

0

null

0

NCT00944450

[ 2 ]

32

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

2MALE

false

The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.

null

Healthy

null

2

arm 1: 0.4 mg Capsule arm 2: 0.4 mg Capsule

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Test 0.4 mg Capsule intervention 2: Reference Listed 0.4 Capsule

intervention 1: Tamsulosin intervention 2: Tamsulosin

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT01149733

[ 3 ]

502

RANDOMIZED

PARALLEL

1PREVENTION

null

false

0ALL

null

The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events. A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.

null

Atrial Fibrillation

null

10

arm 1: Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid). arm 2: Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning. arm 3: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 4: Dabigatran: one capsule in the morning and 1 capsule in the evening arm 5: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 6: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 7: Dabigatran: one capsule in the morning and 1 capsule in the evening arm 8: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 9: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 10: once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 1 ]

10

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: dose comparison in combination intervention 2: dose comparison in combination intervention 3: dose comparison in combination intervention 4: dose comparison in combination intervention 5: dose comparison in combination intervention 6: dose comparison in combination intervention 7: comparator intervention 8: dose comparison intervention 9: dose comparison intervention 10: dose comparison

intervention 1: dabigatran with ASA intervention 2: dabigatran with ASA intervention 3: dabigatran with ASA intervention 4: dabigatran with ASA intervention 5: dabigatran with ASA intervention 6: dabigatran with ASA intervention 7: warfarin intervention 8: dabigatran without ASA intervention 9: dabigatran without ASA intervention 10: dabigatran without ASA

38

Fayetteville | Arkansas | United States | -94.15743 | 36.06258 La Mesa | California | United States | -117.02308 | 32.76783 Pensacola | Florida | United States | -87.21691 | 30.42131 Port Charlotte | Florida | United States | -82.09064 | 26.97617 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Baltimore | Maryland | United States | -76.61219 | 39.29038 Westminister | Maryland | United States | -75.96856 | 39.64733 Pittsfield | Massachusetts | United States | -73.24538 | 42.45008 Troy | Michigan | United States | -83.14993 | 42.60559 Hawthorne | New York | United States | -73.79597 | 41.10732 New Hyde Park | New York | United States | -73.68791 | 40.7351 North Durham | North Carolina | United States | N/A | N/A Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Germantown | Tennessee | United States | -89.81009 | 35.08676 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus C | N/A | Denmark | 10.21231 | 56.16558 Brædstrup | N/A | Denmark | 9.61129 | 55.97153 Elsinore | N/A | Denmark | 12.6136 | 56.03606 Esbjerg | N/A | Denmark | 8.45187 | 55.47028 Frederikssund | N/A | Denmark | 12.06896 | 55.83956 Herlev | N/A | Denmark | 12.43998 | 55.72366 Holbæk | N/A | Denmark | 11.71279 | 55.7175 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Køge | N/A | Denmark | 12.18214 | 55.45802 Odense | N/A | Denmark | 10.38831 | 55.39594 Roskilde | N/A | Denmark | 12.08035 | 55.64152 Svendborg | N/A | Denmark | 10.60677 | 55.05982 Eskilstuna | N/A | Sweden | 16.5077 | 59.36661 Falun | N/A | Sweden | 15.62597 | 60.60357 Jönköping | N/A | Sweden | 14.15618 | 57.78145 Kalmar | N/A | Sweden | 16.36163 | 56.66157 Malmo | N/A | Sweden | 13.00073 | 55.60587 Norrköping | N/A | Sweden | 16.1826 | 58.59419 Örebro | N/A | Sweden | 15.2066 | 59.27412 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Umeå | N/A | Sweden | 20.25972 | 63.82842 Västerås | N/A | Sweden | 16.55276 | 59.61617

0

NCT01227629

[ 4 ]

605

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

null

Anemia

null

2

arm 1: Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months. arm 2: Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to \<10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase. intervention 2: Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred.

intervention 1: epoetin beta [NeoRecormon] intervention 2: epoetin beta [NeoRecormon]

93

Linz | N/A | Austria | 14.28611 | 48.30639 Sankt Pölten | N/A | Austria | 15.63333 | 48.2 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662 Brno | N/A | Czechia | 16.60796 | 49.19522 Havířov | N/A | Czechia | 18.43688 | 49.77984 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Fredericia | N/A | Denmark | 9.75257 | 55.56568 Herlev | N/A | Denmark | 12.43998 | 55.72366 Holbæk | N/A | Denmark | 11.71279 | 55.7175 Roskilde | N/A | Denmark | 12.08035 | 55.64152 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Tampere | N/A | Finland | 23.78712 | 61.49911 Amiens | N/A | France | 2.3 | 49.9 Angoulême | N/A | France | 0.15345 | 45.64997 Bordeaux | N/A | France | -0.5805 | 44.84044 Boulogne | N/A | France | -1.3194 | 46.79346 Colmar | N/A | France | 7.35584 | 48.08078 Lyon | N/A | France | 4.84671 | 45.74846 Montpellier | N/A | France | 3.87635 | 43.61093 Paris | N/A | France | 2.3488 | 48.85341 Saint-Brieuc | N/A | France | -2.76838 | 48.51513 Troyes | N/A | France | 4.08524 | 48.30073 Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 Berlin | N/A | Germany | 13.41053 | 52.52437 Villingen-Schwenningen | N/A | Germany | 8.49358 | 48.06226 Würzburg | N/A | Germany | 9.95121 | 49.79391 Athens | N/A | Greece | 23.72784 | 37.98376 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Véria | N/A | Greece | 22.55173 | 37.19027 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Dublin | N/A | Ireland | -6.24889 | 53.33306 Bologna | N/A | Italy | 11.33875 | 44.49381 Busto Arsizio | N/A | Italy | 8.84914 | 45.61128 Cagliari | N/A | Italy | 9.11917 | 39.23054 Cinisello Balsamo | N/A | Italy | 9.21495 | 45.55823 Lecco | N/A | Italy | 9.39704 | 45.85589 Napoli | N/A | Italy | 14.5195 | 40.87618 Padua | N/A | Italy | 11.88586 | 45.40797 Parma | N/A | Italy | 10.32618 | 44.79935 Pavia | N/A | Italy | 9.15917 | 45.19205 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 San Giovanni Rotondo | N/A | Italy | 15.7277 | 41.70643 Trieste | N/A | Italy | 13.77678 | 45.64953 Vimercate | N/A | Italy | 9.36801 | 45.61545 Cuernavaca | N/A | Mexico | -99.23075 | 18.9261 Tijuana | N/A | Mexico | -117.00371 | 32.5027 Oslo | N/A | Norway | 10.74609 | 59.91273 Gdansk | N/A | Poland | 18.64912 | 54.35227 Kielce | N/A | Poland | 20.62752 | 50.87033 Krakow | N/A | Poland | 19.93658 | 50.06143 Wroclaw | N/A | Poland | 17.03333 | 51.1 Almada | N/A | Portugal | -9.1569 | 38.67902 Carnaxide | N/A | Portugal | -9.24671 | 38.72706 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Porto | N/A | Portugal | -8.61099 | 41.14961 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Barcelona | N/A | Spain | 2.15899 | 41.38879 Las Palmas de Gran Canaria | N/A | Spain | -15.41343 | 28.09973 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Valencia | N/A | Spain | -0.37966 | 39.47391 Borås | N/A | Sweden | 12.9401 | 57.72101 Helsingborg | N/A | Sweden | 12.69437 | 56.04673 Jönköping | N/A | Sweden | 14.15618 | 57.78145 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Norrköping | N/A | Sweden | 16.1826 | 58.59419 Örebro | N/A | Sweden | 15.2066 | 59.27412 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Sundsvall | N/A | Sweden | 17.3063 | 62.39129 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 London | N/A | United Kingdom | -0.12574 | 51.50853 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 Salford | N/A | United Kingdom | -2.29042 | 53.48771 Southampton | N/A | United Kingdom | -1.40428 | 50.90395 Surrey | N/A | United Kingdom | N/A | N/A

1

NCT00321919

[ 3 ]

67

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

OBJECTIVES: Primary: * Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan. Secondary: * Determine the time to treatment failure, time to overall response, duration of overall response, duration of overall complete response, and time to progression in patients treated with this regimen. * Determine the 1-year survival and overall survival of patients treated with this regimen. * Determine the toxicity and safety profile of this regimen in these patients. * Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.

Colorectal Cancer

stage III colon cancer stage IV colon cancer stage III rectal cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum

null

2

arm 1: Participants will receive capecitabine (Xeloda) 1000 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). arm 2: Participants will receive capecitabine 900 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Capecitabine intervention 2: Irinotecan

17

0

NCT00022698

[ 3 ]

52

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate T-20 in children.

Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.

HIV Infections

Anti-HIV Agents pentafuside

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Enfuvirtide

7

0

NCT00022763

[ 4 ]

1,609

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

null

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

null

Post Menopausal Osteoporosis

null

4

arm 1: Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . arm 2: Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. arm 3: Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day arm 4: Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day

[ 1, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 7, 7 ]

intervention 1: 2.5mg po daily intervention 2: 100mg po monthly on a single day intervention 3: 100mg po monthly over 2 consecutive days intervention 4: 150mg po monthly intervention 5: 500 mg/day intervention 6: 400 IU/day

intervention 1: Ibandronate [Bonviva/Boniva] intervention 2: Ibandronate [Bonviva/Boniva] intervention 3: Ibandronate [Bonviva/Boniva] intervention 4: Ibandronate [Bonviva/Boniva] intervention 5: Calcium intervention 6: Vitamin D

68

Irvine | California | United States | -117.82311 | 33.66946 Loma Linda | California | United States | -117.26115 | 34.04835 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Rancho Mirage | California | United States | -116.41279 | 33.73974 Lakewood | Colorado | United States | -105.08137 | 39.70471 Gainesville | Florida | United States | -82.32483 | 29.65163 Bethesda | Maryland | United States | -77.10026 | 38.98067 Wheaton | Maryland | United States | -77.05526 | 39.03983 St Louis | Missouri | United States | -90.19789 | 38.62727 Billings | Montana | United States | -108.50069 | 45.78329 Omaha | Nebraska | United States | -95.94043 | 41.25626 Livingston | New Jersey | United States | -74.31487 | 40.79593 Albuquerque | New Mexico | United States | -106.65114 | 35.08449 Portland | Oregon | United States | -122.67621 | 45.52345 Wyomissing | Pennsylvania | United States | -75.96521 | 40.32954 San Antonio | Texas | United States | -98.49363 | 29.42412 Richmond | Virginia | United States | -77.46026 | 37.55376 Seattle | Washington | United States | -122.33207 | 47.60621 Madison | Wisconsin | United States | -89.40123 | 43.07305 Adelaide | N/A | Australia | 138.59863 | -34.92866 Adelaide | N/A | Australia | 138.59863 | -34.92866 Parkville | N/A | Australia | 144.95 | -37.78333 Perth | N/A | Australia | 115.8614 | -31.95224 Liège | N/A | Belgium | 5.56749 | 50.63373 Merksem | N/A | Belgium | 4.44903 | 51.24623 Campinas | N/A | Brazil | -47.06083 | -22.90556 Curitiba | N/A | Brazil | -49.27306 | -25.42778 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Calgary | Alberta | Canada | -114.08529 | 51.05011 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Toronto | Ontario | Canada | -79.39864 | 43.70643 Québec | Quebec | Canada | -71.21454 | 46.81228 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Aalborg | N/A | Denmark | 9.9187 | 57.048 Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165 Vejle | N/A | Denmark | 9.5357 | 55.70927 Caen | N/A | France | -0.35912 | 49.18585 Lyon | N/A | France | 4.84671 | 45.74846 Berlin | N/A | Germany | 13.41053 | 52.52437 Hanover | N/A | Germany | 9.73322 | 52.37052 Balatonfüred | N/A | Hungary | 17.87187 | 46.96188 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Kiskunhalas | N/A | Hungary | 19.48479 | 46.43402 Zalaegerszeg | N/A | Hungary | 16.84389 | 46.84 Siena | N/A | Italy | 11.33064 | 43.31822 Valeggio sul Mincio | N/A | Italy | 10.73635 | 45.35333 León | N/A | Mexico | -113.78333 | 28.51667 Obregón | N/A | Mexico | -109.63445 | 26.82768 Haugesund | N/A | Norway | 5.268 | 59.41378 Oslo | N/A | Norway | 10.74609 | 59.91273 Stavanger | N/A | Norway | 5.73332 | 58.97005 Krakow | N/A | Poland | 19.93658 | 50.06143 Warsaw | N/A | Poland | 21.01178 | 52.22977 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Zurich | N/A | Switzerland | 8.55 | 47.36667 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 London | N/A | United Kingdom | -0.12574 | 51.50853 Southampton | N/A | United Kingdom | -1.40428 | 50.90395

0

NCT00048061

[ 3 ]

253

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in the shape and pumping ability of the heart. These changes can lead to heart failure. An enzyme called metalloproteinase (MMP) plays a role in this damage. The main purpose of the study is to test whether a possible new drug (called PG-116800) that interferes with the MMP enzyme can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease. This is a Phase II "proof-of-concept" study; that is, it is a first attempt to treat sick people with the drug to see if it works. The study is interventional since we will be using a drug to interfere with the heart tissue damage that follows a heart attack.

Myocardial Infarction Heart Failure Heart Enlargement

null

2

arm 1: PG-116800 tablet (200 mg) taken twice daily for 90 days arm 2: Placebo tablet taken twice daily for 90 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days intervention 2: placebo tablet, twice a day for 90 days

intervention 1: PG-116800 (given as PG-530742) intervention 2: Placebo tablet

52

0

NCT00067236

[ 4 ]

254

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

null

Excessive Sleepiness Shift Work Sleep Disorder

Excessive Sleepiness Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cephalon Cephalon, Inc Nuvigil

null

2

arm 1: Armodafinil 150 mg/day arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked. intervention 2: Matching placebo tablets once daily

intervention 1: Armodafinil 150 mg/day intervention 2: Placebo

0

null

0

NCT00080288

[ 3 ]

180

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Schizophrenia

Schizophrenia Latuda Lurasidone

null

2

arm 1: 80 mg AM dosing once daily arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 80 mg AM dosing once daily intervention 2: Matching Placebo to 40mg lurasidone tablets

intervention 1: Lurasidone intervention 2: Placebo

22

0

NCT00088634

[ 4 ]

596

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.

Chronic Hepatitis C

Chronic hepatitis C, Ursodeoxycholic acid

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Ursodeoxycholic acid, 150mg/ day, three times a day at meals intervention 2: Ursodeoxycholic acid, 600mg/ day, three times a day at meals intervention 3: Ursodeoxycholic acid, 900mg/ day, three times a day at meals

intervention 1: Ursodeoxycholic acid 150mg / day intervention 2: Ursodeoxycholic acid 600mg / day intervention 3: Ursodeoxycholic acid 900mg / day

1

Hongo, Bunkyo-ku, Tokyo | N/A | Japan | N/A | N/A

0

NCT00200343

[ 3 ]

110

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.

This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neonatal Facial Action Coding System (NFCS) which is currently the gold standard for infant pain assessment, latency to first cry and cry duration. Parents' (father) perception of infant's pain will be assessed using a visual analogue scale (VAS) when possible. Neonates will be randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS.

Pain

Infant,newborn Topical anesthesia Intramuscular injection

null

2

arm 1: 1 g of topical amethocaine gel 4% arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 1g, single application intervention 2: 1 g, single application

intervention 1: Eucerin plus intervention 2: Amethocaine gel 4%

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT00267111

[ 0 ]

7

NA

SINGLE_GROUP

6HEALTH_SERVICES_RESEARCH

0NONE

true

0ALL

false

Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis, AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown. Although only approved to combat weight loss associated with AIDS and cancer, MA is frequently prescribed for long periods of time to prevent or reverse weight loss in nursing home residents and in elderly patients with serious illnesses in the community. Little data is available to support this practice. Among its many properties, MA acts as a partial glucocorticoid agonist, and long term and short term use of MA may results in adrenal suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course of resumption of normal adrenal function after discontinuation of MA is completely unknown. As a consequence, it is unclear whether MA can be given safely for short periods of time or whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a substantial risk of adrenal crisis after an illness, requires a clear understanding of these issues. To address these concerns, we will evaluate adrenal function before, during, and after MA administration in healthy volunteers between the ages of 60 and 85 years.

null

Adrenal Insufficiency

megestrol acetate adrenal insufficiency adrenal suppression

null

1

arm 1: Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of adrenal status every two weeks by measurement of serum electrolytes, serum cortisol, serum adrenocorticotropic hormone(ACTH) levels, and the adrenal response to a low dose ACTH (1µgm) stimulation test(see methods).

[ 0 ]

1

[ 0 ]

intervention 1: 600 mg by mouth daily

intervention 1: megestrol acetate

1

Little Rock | Arkansas | United States | -92.28959 | 34.74648

0

NCT00575029

[ 3 ]

4

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially replace glucose.

null

End-Stage Renal Disease

Peritoneal dialysis L-carnitine

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution for 5 days.

intervention 1: L-carnitine

1

Chieti | N/A | Italy | 14.16494 | 42.34827

0

NCT00922701

[ 2 ]

132

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.

Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).

Healthy Volunteers

Healthy subjects Opioid Transdermal

null

3

arm 1: Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h. arm 2: Matching placebo transdermal patches 5, 10, 20 and 2 \* 20. arm 3: Moxifloxacin hydrochloride 400 mg tablets

[ 0, 2, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h. intervention 2: Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20. intervention 3: Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13

intervention 1: Buprenorphine transdermal patch intervention 2: Matching placebo transdermal patch intervention 3: Avelox (moxifloxacin hydrochloride) tablet

1

Austin | Texas | United States | -97.74306 | 30.26715

0

NCT01148537

[ 4 ]

507

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.

Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD.

Multiple Sclerosis Spasticity Pain

null

1

arm 1: Active treatment

[ 0 ]

1

[ 0 ]

intervention 1: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.

intervention 1: GW-1000-02

1

Glasgow | N/A | United Kingdom | -4.25763 | 55.86515

0

NCT01606137

[ 2 ]

18

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

2MALE

false

Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers

Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data. Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.

Epilepsy

Anticonvulsant

null

3

arm 1: 3 tablets of BIA 2-093 600 mg arm 2: 4 tablets of BIA 2-093 600 mg arm 3: placebo tablets

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 3 tablets of BIA 2-093 intervention 2: 4 tablets of BIA 2-093 600 mg intervention 3: placebo tablets

intervention 1: BIA 2-093 - 1800 mg (Group 1) intervention 2: BIA 2-093 - 2400 mg (Group 2) intervention 3: Placebo

1

Trofa | Coronado (S.Romão E S. Mamede) | Portugal | -8.5596 | 41.33729

0

NCT01879345

[ 3 ]

40

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.

OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Glioblastoma Multiforme of Brain

adult glioblastoma

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003456

[ 2 ]

45

RANDOMIZED

SEQUENTIAL

0TREATMENT

3TRIPLE

false

null

true

The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

null

Osteoporosis

Postmenopausal Denosumab

null

2

arm 1: Participants received a single subcutaneous injection of placebo to denosumab on day 1. arm 2: Participants received a single subcutaneous dose of denosumab on day 1. Doses included 0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg.

[ 2, 0 ]

2

[ 0, 2 ]

intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

intervention 1: Placebo intervention 2: Denosumab

0

null

0

NCT03822078

[ 3 ]

75

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

null

Attention Deficit Disorder With Hyperactivity

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Methylphenidate + SPD503 (Guanfacine hydrochloride) intervention 2: Amphetamine + SPD503

0

null

0

NCT00151996

[ 4 ]

196

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)

null

Narcolepsy

Narcolepsy Excessive Sleepiness Cataplexy Sleep Attacks Excessive Sleepiness associated with Narcolepsy Cephalon Cephalon, Inc Nuvigil

null

3

arm 1: Armodafinil 250 mg arm 2: Armodafinil 150 mg arm 3: Placebo

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily

intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Placebo

0

null

0

NCT00078377

[ 4 ]

116

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.

This was a multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of GW-1000-02 in central neuropathic pain associated with spinal cord injury. Patients were screened to determine eligibility and completed a seven to 21 day baseline period. Patients then returned to the centre for assessment, randomisation and initial dosing. Visits occurred at the end of treatment week one and at the end of the study (treatment week three) or upon withdrawal. Throughout the study, patients were permitted to take paracetamol as escape analgesic to relieve breakthrough pain. Patients in this study could elect to be screened for an open label extension study of GW-1000-02.

Pain

null

2

arm 1: Active treatment. arm 2: Placebo control.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period. intervention 2: Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.

intervention 1: GW-1000-02 intervention 2: Placebo

1

Middlesex | N/A | United Kingdom | -0.26856 | 51.53174

0

NCT01606202

[ 3 ]

9

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The study is planned to be conducted in 2 parts. The first part (open label, multi-center, non-controlled) of the study will estimate a dose that would provide a mycophenolic acid (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver transplant participants receiving the approved dose of mycophenolate mofetil (MMF, CellCept). The second part (open-label, multi-center, single-arm Phase IV study) of the study will provide the pharmacokinetics, efficacy and safety profile of the proposed dose in the immediate post-transplant period. This study will be conducted at two centers based in the United States of America. Twelve pediatric transplant participants receiving a first liver allograft from a cadaveric or living donor will be enrolled in this study. Stable pediatric liver transplant participants who are at least 6 months post-transplant and who were already receiving stable dose of MMF in combination with cyclosporine will be enrolled into the study. Participants should have received stable MMF dose according to center practice for at least seven days in order to get steady state pharmacokinetics (PK). Participants also should have received stable concomitant doses of cyclosporine (for at least 2 days) and corticosteroids per center practice. Participants will be aged between 9 months and 12 years, with at least 6 participants greater than or equal to (\>/=) 9 months and less than (\<) 36 months, of whom at least 2 will be \<24 months.

null

Pediatric Liver Transplantation

null

1

arm 1: Part 1: Participants will receive mycophenolate mofetil. Part 2: Participants will receive mycophenolate mofetil along with cyclosporine and corticosteroids.

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Corticosteroids will be administered as per center practice. The choice of corticosteroid drug will also be based on center practice. intervention 2: Cyclosporine will be administered as per center practice. intervention 3: Part 1: Mycophenolate mofetil will be administered as per center practice. Part 2: Mycophenolate mofetil will be administered as per dose determined in Part 1.

intervention 1: Corticosteroids intervention 2: Cyclosporine intervention 3: mycophenolate mofetil

2

0

NCT02630563