ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00684723
Conditions: Healthy
Keywords: Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-07-01; Completion date: 2004-07-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: 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.
Interventions: intervention 1: Lovastatin 40 mg Tablets intervention 2: Lovastatin (Mevacor®) 40 mg Tablets
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00685802
Conditions: Therapeutic Equivalency, Healthy
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-06-01; Completion date: 2004-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: 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.
Interventions: intervention 1: Cilostazol 50 mg Tablets intervention 2: Cilostazol (Pletal®) 50 mg Tablets
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00829179
Conditions: Allergic Asthma
Keywords: Asthma
Sponsor: Duke University
Start date: 2002-10-01; Completion date: 2004-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Interventions: intervention 1: RhuMab-E25
Intervention descriptions: intervention 1: three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.

Protocol documents:
Clinical trial NCT00833911
Conditions: Osteoarthritis, Knee
Keywords: Moderate to severe symptomatic osteoarthritis of the knee
Sponsor: Labopharm Inc.
Start date: 2003-04-01; Completion date: 2004-07-01
Enrollment: 392 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tramadol Once A Day
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01045967
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2004-05-01; Completion date: 2004-07-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Lansoprazole 30 mg delayed-release Capsules arm 2: Prevacid® 30 mg delayed-release Capsules
Interventions: intervention 1: Lansoprazole intervention 2: Prevacid®
Intervention descriptions: intervention 1: 30 mg delayed-release Capsule intervention 2: 30 mg delayed-release Capsule

Protocol documents:
Clinical trial NCT01141283
Conditions: Osteoarthritis
Keywords: Osteoarthritis Opioid Transdermal
Sponsor: Purdue Pharma LP
Start date: 2003-04-01; Completion date: 2004-07-01
Enrollment: 290 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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

Detailed description:
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.

Arms: arm 1: Buprenorphine transdermal patch
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00117143
Conditions: Thrombocytopenic Purpura
Keywords: Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia
Sponsor: Amgen
Start date: 2002-12-02; Completion date: 2004-07-19
Enrollment: 16 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
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.

Detailed description:

Arms: 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.
Interventions: intervention 1: Romiplostim
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00326781
Conditions: Smoking
Keywords: Nicotine nasal spray + counseling Transdermal nicotine + counseling
Sponsor: University of Pennsylvania
Start date: 1999-12-01; Completion date: 2004-08-01
Enrollment: 674 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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).

Detailed description:
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.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nicoderm Transdermal Patch intervention 2: Nicotine Nasal Spray
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT01469052
Conditions: Advanced Solid Tumors
Sponsor: Pfizer
Start date: 2002-11-01; Completion date: 2004-08-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: AG-013736 intervention 2: AG-013736 intervention 3: AG-013736 intervention 4: AG-013736 intervention 5: AG-013736 intervention 6: AG-013736
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00077675
Conditions: Infections, Gram-positive Bacterial
Keywords: Abscess Burns Cellulitis Ulcer Wound infections
Sponsor: Cumberland Pharmaceuticals
Start date: 2004-02-01; Completion date: 2004-09-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: cSSSI - comlicated skin and skin structure infections
Interventions: intervention 1: Telavancin intervention 2: vancomycin or antistaphylococcal penicillin
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00224055
Conditions: Anemia, Iron-Deficiency Kidney Failure, Chronic
Keywords: Iron deficiency Anemia Chronic kidney disease Sodium Ferric Gluconate Anemia, Iron-Deficiency/drug therapy/etiology Kidney Failure, Chronic/blood/complications/therapy
Sponsor: Watson Pharmaceuticals
Start date: 2003-04-01; Completion date: 2004-09-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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).

Detailed description:

Arms: arm 1: Sodium ferric gluconate arm 2: ferrous sulfate
Interventions: intervention 1: Sodium Ferric Gluconate Complex in Sucrose Injection intervention 2: Ferrous sulfate tablets
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT01149460
Conditions: Healthy
Sponsor: Teva Pharmaceuticals USA
Start date: 2004-09-01; Completion date: 2004-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: Test 1000 mg Tablet arm 2: Reference Listed Valacyclovir 1000 mg Tablet
Interventions: intervention 1: Valacyclovir intervention 2: Valacyclovir
Intervention descriptions: intervention 1: Test 1000 mg Tablet intervention 2: Reference Listed Valacyclovir 1000 mg Tablet

Protocol documents:
Clinical trial NCT01218971
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence
Sponsor: Alkermes, Inc.
Start date: 2002-08-01; Completion date: 2004-09-01
Enrollment: 332 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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).

Arms: 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.
Interventions: intervention 1: Medisorb naltrexone 190 mg intervention 2: Medisorb naltrexone 380 mg
Intervention descriptions: intervention 1: naltrexone for extended-release injectable suspension intervention 2: naltrexone for extended-release injectable suspension

Protocol documents:
Clinical trial NCT00058539
Conditions: Prostate Cancer
Sponsor: Genentech, Inc.
Start date: 2003-04-01; Completion date: 2004-10-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:

Interventions: intervention 1: rhuMAb 2C4 (pertuzumab)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00079677
Conditions: Obstructive Sleep Apnea Sleep Hypopnea
Keywords: Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc Nuvigil
Sponsor: Cephalon
Start date: 2004-03-01; Completion date: 2004-10-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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).

Detailed description:

Arms: arm 1: Armodafinil 150 mg/day arm 2: Placebo
Interventions: intervention 1: Armodafinil 150 mg/day intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil 150 mg once daily in the morning intervention 2: Matching placebo tablets once daily

Protocol documents:
Clinical trial NCT00090142
Conditions: Asthma, Exercise-Induced
Sponsor: Organon and Co
Start date: 2004-05-01; Completion date: 2004-10-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: Montelukast - Placebo arm 2: Placebo - Montelukast
Interventions: intervention 1: Comparator: Montelukast intervention 2: Comparator: Placebo
Intervention descriptions: 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

Protocol documents: