ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00711880
Conditions: Pain Peripheral Neuropathy
Keywords: Pain Peripheral Neuropathy
Sponsor: Jazz Pharmaceuticals
Start date: 2002-05-01; Completion date: 2004-03-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed description:
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.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sativex® intervention 2: Placebo
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00911742
Conditions: Pain
Sponsor: Labopharm Inc.
Start date: 2004-02-01; Completion date: 2004-03-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tramadol Contramid OAD intervention 2: Zytram
Intervention descriptions: intervention 1: 1 Tramadol Contramid OAD 200 mg tablet as a single dose intervention 2: 1 Zytram 200 mg tablet as a single dose

Protocol documents:
Clinical trial NCT01740362
Conditions: Renal Impairment
Keywords: CP-690 550 pharmacokinetics renal impairment
Sponsor: Pfizer
Start date: 2003-10-01; Completion date: 2004-03-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT02279667
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2004-02-01; Completion date: 2004-03-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: 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
Interventions: intervention 1: BIA 2-093 intervention 2: BIA 2-093 intervention 3: BIA 2-093
Intervention descriptions: intervention 1: oral suspension 50 mg/mL intervention 2: 200 mg tablet intervention 3: 800 mg tablet

Protocol documents:
Clinical trial NCT00009737
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 1998-11-01; Completion date: 2004-04-01
Enrollment: 1987 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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).
Interventions: intervention 1: 5-Fluorouracil intervention 2: Leucovorin intervention 3: Capecitabine [Xeloda]
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00174915
Conditions: Gout
Keywords: Uric Acid, gout, xanthine oxidase, febuxostat, tophi
Sponsor: Takeda
Start date: 2003-02-01; Completion date: 2004-04-01
Enrollment: 1072 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed description:
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.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat intervention 4: Allopurinol intervention 5: Placebo
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00928694
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2003-02-01; Completion date: 2004-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: Fenofibrate U.S. Formulation arm 2: Fenofibrate UK Formulation
Interventions: intervention 1: fenofibrate (U.S. formulation) intervention 2: fenofibrate (UK formulation)
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT01149473
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2004-03-01; Completion date: 2004-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets
Interventions: intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Losartan potassium/Hydrochlorothiazide
Intervention descriptions: intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets

Protocol documents:
Clinical trial NCT01736696
Conditions: Psoriasis Immunomodulation
Keywords: Psoriasis PASI plaques skin biopsy immunomodulation
Sponsor: Pfizer
Start date: 2002-11-01; Completion date: 2004-04-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: tofacitinib intervention 2: tofacitinib intervention 3: tofacitinib intervention 4: tofacitinib intervention 5: tofacitinib intervention 6: tofacitinib
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00239590
Conditions: Coronary Heart Disease
Sponsor: Imperial College London
Start date: 2001-06-01; Completion date: 2004-04-24
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: 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
Interventions: intervention 1: Testosterone undecanoate
Intervention descriptions: intervention 1: Licensed for androgen deficiency

Protocol documents:
Clinical trial NCT00041717
Conditions: Spinal Cord Injury Muscle Spasticity
Keywords: spinal cord injury muscle spasticity
Sponsor: Acorda Therapeutics
Start date: 2002-07-01; Completion date: 2004-05-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fampridine-SR intervention 2: Placebo
Intervention descriptions: intervention 1: 25mg bid (twice daily) intervention 2: Placebo

Protocol documents:
Clinical trial NCT00092118
Conditions: Rhinitis, Allergic, Perennial
Sponsor: Organon and Co
Start date: 2003-10-01; Completion date: 2004-05-01
Enrollment: 1992 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

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

Protocol documents:
Clinical trial NCT00658541
Conditions: Healthy Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-05-01; Completion date: 2004-05-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: 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.
Interventions: intervention 1: Zolpidem Tartrate 10 mg tablet intervention 2: Zolpidem Tartrate 10 mg tablet (Ambien®)
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00684814
Conditions: Healthy
Keywords: equivalency Therapeutic equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-05-01; Completion date: 2004-05-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: 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.
Interventions: intervention 1: Zolpidem Tartrate 10 mg tablet intervention 2: Zolpidem Tartrate 10 mg tablet (Ambien®)
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00950599
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2003-05-01; Completion date: 2004-05-01
Enrollment: 423 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Saxagliptin intervention 6: Saxagliptin intervention 7: Placebo
Intervention descriptions: 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

Protocol documents: