ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01014624
Conditions: Coronary Artery Disease
Keywords: thienopyridine pharmacologic action prasugrel clopidogrel
Sponsor: Daiichi Sankyo
Start date: 2010-02-01; Completion date: 2010-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The primary analysis is descriptive and is intended to provide information relating to the return of baseline platelet function following discontinuation of maintenance therapy with either prasugrel or clopidogrel.

Detailed description:

Arms: arm 1: Prasugrel 10mg administered for 7 days followed by a Washout Period up to 12 days. arm 2: Clopidogrel 75mg administered for 7 days followed by a 12 day Washout Period up to 12 days.
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Prasugrel 10mg tablet administered once daily for 7 days.

After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria. intervention 2: Clopidogrel 75 mg tablet administered once daily for 7 days.

After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria.

Protocol documents:
Clinical trial NCT01029795
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2010-02-01; Completion date: 2010-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to help answer the following research question(s):

* To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks.
* To evaluate the safety of LY2599506 in participants with diabetes.
* To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
* To determine how much LY2599506 should be given to participants.
* To determine if LY2599506 has an effect on a participant's weight.

The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow up period.

Detailed description:

Arms: arm 1: Combinations of 50-milligram (mg) or 100-mg capsules of LY2599506 or matching placebo capsules (each dose contains at least 1 capsule of active drug). LY2599506 will be administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day. arm 2: Combinations of 2.5-mg capsules of Glyburide or matching placebo capsules (each dose contains at least 1 capsule of active drug). Glyburide will be administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
Interventions: intervention 1: LY2599506 intervention 2: Glyburide intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks intervention 2: Administered po, BID daily prior to morning and evening meals for 12 weeks intervention 3: Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks

Protocol documents:
Clinical trial NCT01033487
Conditions: Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Chronic Obstructive Airway Disease COPD
Keywords: Safety Pharmacokinetics Pharmacodynamics PF-03635659 COPD
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2010-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: placebo intervention 2: active comparator intervention 3: Low Dose PF-03635659 intervention 4: Mid Dose PF-03635659 intervention 5: High Dose PF-03635659
Intervention descriptions: intervention 1: oral inhaled formulation, single dose intervention 2: oral inhaled formulation, single dose intervention 3: oral inhaled formulation, single dose, low dose intervention 4: oral inhaled formulation, single dose, mid dose intervention 5: oral inhaled formulation, single dose, high dose

Protocol documents:
Clinical trial NCT01033864
Conditions: Kidney Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2009-11-01; Completion date: 2010-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.

Detailed description:

Arms: arm 1: Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month. arm 2: Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month.
Interventions: intervention 1: MMF intervention 2: EC-MPS intervention 3: Prednisone
Intervention descriptions: intervention 1: 1 g per day b.i.d. p.o. for at least 1 month intervention 2: 720 mg b.i.d. p.o. for at least 1 month intervention 3: 5 mg per day p.o.

Protocol documents:
Clinical trial NCT01037881
Conditions: Atopic Dermatitis
Sponsor: LEO Pharma
Start date: 2009-12-01; Completion date: 2010-06-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.

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: LEO 29102 intervention 2: Elidel®
Intervention descriptions: intervention 1: comparison of different dosages of drug intervention 2: comparison

Protocol documents:
Clinical trial NCT01043393
Conditions: Psoriasis
Keywords: Plaque psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2010-02-01; Completion date: 2010-06-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the potential of desoximetasone 0.25% topical spray to suppress HPA axis function. The potential for adrenal suppression will be assessed following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters and to evaluate the adverse event (AE) profile.

Detailed description:

Arms: arm 1: Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area. arm 2: Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area.
Interventions: intervention 1: Desoximetasone 0.25% spray
Intervention descriptions: intervention 1: Desoximetasone spray applied to affected areas twice daily for 28 days

Protocol documents:
Clinical trial NCT01048593
Conditions: Inflammatory Reaction Due to Ocular Lens Prosthesis
Keywords: ocular inflammation cataract surgery post cataract surgery inflammation
Sponsor: ICON Bioscience Inc
Start date: 2010-01-01; Completion date: 2010-06-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.

Detailed description:
All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.

Arms: arm 1: 114ug arm 2: 513ug arm 3: 684ug
Interventions: intervention 1: IBI-10090
Intervention descriptions: intervention 1: Single intraocular injection

Protocol documents:
Clinical trial NCT01058863
Conditions: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-02-01; Completion date: 2010-06-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

Detailed description:

Arms: arm 1: A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind. arm 2: A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind. arm 3: A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind. arm 4: A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind. arm 5: Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
Interventions: intervention 1: Albuterol Spiromax® intervention 2: ProAir® HFA intervention 3: Placebo Inhaler
Intervention descriptions: intervention 1: Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg. intervention 2: ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg. intervention 3: Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.

Protocol documents:
Clinical trial NCT01063868
Conditions: Diabetic Neuropathy, Painful Diabetic Polyneuropathy
Keywords: Diabetic neuropathy Painful Polyneuropathy Peripheral neuropathy
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2010-01-01; Completion date: 2010-06-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.

Detailed description:
This is a randomized, open-label, active-controlled, multicenter study evaluating the safety profile of orally administered tapentadol, using the extended release tamper-resistant formulation (TRF), at dosages of 100 to 250 mg twice daily in patients with moderate to severe pain due to chronic, painful DPN. The study consists of 1) a 13-day screening period, a 3-7-day washout period (where patients are to stop taking their pain medication), a 1-day pretitration pain-intensity evaluation period (where patients will record their 24-hour pain intensity), and a 3-week, open-label titration period (patients will receive either tapentadol ER or oxycodone CR study drug in a 3 to 1 ratio), 2) a 49-week, open-label maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days. The study will evaluate the safety and tolerability of orally administered tapentadol ER by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), opioid withdrawal scales, assessment of patient-reported constipation, standardized neurologic examinations and monitoring of adverse events. Assessments of pain relief include the pain intensity numerical rating scale, and patient global impression of change scale (PGIC). The total duration of study drug treatment for each patient will be approximately 52 weeks. Titrate tapentadol ER 50 mg twice daily or oxycodone CR 10 mg twice daily to patient's optimal dose ranging between 100 mg and 250 mg twice daily or 20 and 50 mg twice daily, respectively. All doses of study medication will be taken orally with or without food for a maximum timeframe of 52 weeks.

Arms: arm 1: Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks arm 2: Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Interventions: intervention 1: Tapentadol extended release (ER) intervention 2: Oxycodone controlled release (CR)
Intervention descriptions: intervention 1: 100, 150, 200, 250 mg twice daily for 52 weeks intervention 2: 20, 30, 40, 50 mg twice daily for 52 weeks

Protocol documents:
Clinical trial NCT01068600
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Indacaterol
Sponsor: Novartis
Start date: 2010-01-01; Completion date: 2010-06-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Detailed description:

Arms: arm 1: Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. arm 2: Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol intervention 2: Placebo to indacaterol
Intervention descriptions: intervention 1: Once daily via single-dose dry powder inhaler (SDDPI) intervention 2: Once daily via SDDPI

Protocol documents:
Clinical trial NCT01090141
Conditions: Obesity Nutrition Disorders Overweight
Keywords: Micafungin Body Weight Anti-Infective Agents Signs and Symptoms Mycoses Therapeutic Uses Antifungal Agents Overnutrition Pharmacologic Actions
Sponsor: University of Texas Southwestern Medical Center
Start date: 2009-11-01; Completion date: 2010-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.

Detailed description:
This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. Exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. Compensation will be provided to the participants for their time.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Micafungin intervention 2: Micafungin
Intervention descriptions: intervention 1: 100 mg IV infusion over 1 hour intervention 2: 300 mg IV infusion over 1 hour

Protocol documents:
Clinical trial NCT01097577
Conditions: Postoperative Pain
Keywords: photorefractive keratectomy excimer laser PRK pain, postoperative pregabalin
Sponsor: 59th Medical Wing
Start date: 2010-03-01; Completion date: 2010-06-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

Detailed description:
Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD (Department of Defense) beneficiaries. Prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular status.

Patients scheduled for PRK surgery will be briefed on the purpose of the study and invited to participate at the preoperative appointment. After the consent process, patients will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg twice daily or placebo for pain control, in addition to the standard care treatment of as needed Percocet and tetracaine ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective pain assessment, adverse drug events and compliance, use of concomitant medications as well as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2 when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10% improvement in pain scores. Secondary outcomes will include measuring healing time, quality of life and use of rescue medications.

Arms: arm 1: Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days arm 2: Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days
Interventions: intervention 1: pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively. intervention 2: 1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.

Protocol documents:
Clinical trial NCT01119443
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-04-01; Completion date: 2010-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.

Detailed description:

Arms: arm 1: V4: PPX ER 1.5mg x 1 fed, V5: PPX ER 0.375mg x 4 fed, V6:: PPX ER 1.5mg x 1 fasted, V5: PPX ER 0.375mg x 4 fasted arm 2: V4: PPX ER 0.375mg x 4 fed, V5: PPX ER 1.5mg x 1 fed, V6:: PPX ER 0.375mg x 4 fasted, V5: PPX ER 1.5mg x 1 fasted
Interventions: intervention 1: PPX ER intervention 2: PPX ER
Intervention descriptions: intervention 1: PPX ER 0.375mg - 1.5mg for 32 days totally intervention 2: PPX ER 0.375mg - 1.5mg for 32 days totally

Protocol documents:
Clinical trial NCT01123395
Conditions: Healthy
Keywords: bioavailability
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2010-05-01; Completion date: 2010-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.

Detailed description:
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. In each of the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice (followed by 220 mL of water) according to the randomization schedule. 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 colchicine. Vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be measured prior to dosing and at 1 hour ± 30 minutes post dose. Subjects will be monitored throughout their participation in the study for adverse reactions.

Arms: arm 1: One Colcrys® (colchicine USP) 0.6 mg intact tablet taken by mouth arm 2: One Colcrys® 0.6 mg tablet crushed and dissolved in apple juice
Interventions: intervention 1: colchicine 0.6 mg tablet intervention 2: colchicine 0.6 mg tablet
Intervention descriptions: intervention 1: One Colcrys® 0.6 mg intact tablet taken by mouth intervention 2: One Colcrys® 0.6 mg tablet dissolved in apple juice

Protocol documents: