ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01237899
Conditions: Chronic Kidney Disease
Keywords: Kidney Renal
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2011-01-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the safety and tolerability of LY2623091 after multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of 16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind for LY2623091 and placebo (negative control), and open label for eplerenone (positive control).

Detailed description:

Arms: arm 1: Daily by mouth for 7 days. arm 2: Daily by mouth for 7 days. arm 3: The anticipated dose of LY2623091 was revised down from the original proposed dose level of 100 mg based on safety and tolerability data. The 25 mg LY2623091 was administered daily by mouth for 7 days. arm 4: The anticipated dose of LY2623091 was revised down from the original proposed dose level of up to 200 mg. The 0.3 mg LY2623091 was determined based on an interim analysis after the third dose level and was administered daily by mouth for 7 days. arm 5: Daily by mouth for 7 days. arm 6: Daily by mouth for 7 days.
Interventions: intervention 1: LY2623091 intervention 2: Placebo intervention 3: Eplerenone
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally. intervention 3: Administered orally.

Protocol documents:
Clinical trial NCT01243957
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2011-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure if there is any difference in how the body breaks down or inactivates either fluoxetine or LY2216684 when both of these medicines are given together. This study will look at how fluoxetine might affect LY2216684 and how giving LY2216684 might affect fluoxetine in the body.

The duration of study participation in this study is approximately 36 days not including the screening appointment. This study requires 1 research unit confinement of 29 days/28 nights followed by 1 outpatient appointment. A screening appointment is required within 30 days prior to the start of the study.

Detailed description:

Arms: arm 1: LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1, 2, and 3 and Days 25-27

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)
Interventions: intervention 1: LY2216684 intervention 2: Fluoxetine
Intervention descriptions: intervention 1: LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27 intervention 2: Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)

Protocol documents:
Clinical trial NCT01249118
Conditions: Healthy Volunteers
Sponsor: Genentech, Inc.
Start date: 2010-11-01; Completion date: 2011-01-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.

Detailed description:

Arms: arm 1: Participants will receive single dose of GDC-0973 2 milligrams (mg) IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. The washout period between each period will be a minimum of 10 days. arm 2: Participants will receive single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. The washout period between each period will be a minimum of 10 days. arm 3: Participants will receive single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. The washout period between each period will be a minimum of 10 days.
Interventions: intervention 1: GDC-0973 IV Infusion intervention 2: GDC-0973 Oral Capsules
Intervention descriptions: intervention 1: IV infusion. intervention 2: Oral dose.

Protocol documents:
Clinical trial NCT01250730
Conditions: Healthy
Keywords: PK profile in Japanese healthy male volunteers
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2011-01-01
Enrollment: 18 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

Detailed description:
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

Arms: arm 1: This study will consist of three cohorts: PF-02341066 150 mg treatment group (n = 6), PF-02341066 250 mg treatment group (n = 6) and PF-02341066 400 mg treatment group (n = 6).
Interventions: intervention 1: PF-02341066 intervention 2: PF-02341066 intervention 3: PF-02341066
Intervention descriptions: intervention 1: Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT. intervention 2: Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs. intervention 3: Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.

Protocol documents:
Clinical trial NCT01250873
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
LY2216684 is being studied as adjunctive treatment for major depressive disorder (MDD) in participants who are partial responders to selective serotonin reuptake inhibitors (SSRIs). Sertraline is a medication that is widely used to treat MDD and is a known substrate of cytochrome P450s (CYP450s), including CYP450 2D6 (CYP2D6), CYP450 2C19 (CYP2C19), CYPP450 3A4 (CYP3A4), and a modest inhibitor of CYP2D6. Based on the diversity of hepatic metabolic clearance pathways for LY2216684 and its elimination by the kidney, it is expected that CYP2D6 inhibition by sertraline will not result in a substantial change in the pharmacokinetic (PK) profile of LY2216684. LY2216684 is only known to be a moderate inhibitor of CYP2C19, so it is unlikely that coadministration of sertraline with LY2216684 will result in a clinically meaningful change in the PK of sertraline. This study is being conducted to test these hypotheses.

Detailed description:

Arms: arm 1: Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3.

Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10.

Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Interventions: intervention 1: LY2216684 intervention 2: Sertraline
Intervention descriptions: intervention 1: po administration intervention 2: po administration

Protocol documents:
Clinical trial NCT01254396
Conditions: Erectile Dysfunction
Keywords: Bioavailability Food Effect Oral Dissolving Tablet (ODT)
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-12-01; Completion date: 2011-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Detailed description:

Arms: arm 1: Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions. arm 2: Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.
Interventions: intervention 1: Sildenafil intervention 2: Sildenafil
Intervention descriptions: intervention 1: Orally Disintegrating Tablet, 50 mg, Single Dose intervention 2: Orally Disintegrating Tablet, 50 mg, Single Dose

Protocol documents:
Clinical trial NCT01263106
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2011-01-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to confirm that LY2216684 is not an inhibitor of cytochrome P450 1A2 (CYP1A2) in healthy participants using theophylline as a probe substrate for the enzyme. Because LY2216684 has been observed to increase heart rate in some healthy participants, this study will also assess heart rate when coadministered with theophylline.

Detailed description:

Arms: arm 1: Period 1: single 200-milligram (mg) theophylline oral dose on Day 1; Washout period of at least 7 days; Period 2: 18 mg LY2216684 orally, once daily on Days 1-5 with single 200-mg theophylline oral dose coadministered on Day 3 arm 2: Period 1: 18 mg LY2216684 orally, once daily on Days 1-5 with single 200-mg theophylline oral dose coadministered on Day 3; Washout period of at least 7 days; Period 2: single 200-mg theophylline oral dose on Day 1
Interventions: intervention 1: LY2216684 intervention 2: Theophylline
Intervention descriptions: intervention 1: 18-mg LY2216684 oral dose intervention 2: 200-mg theophylline oral dose

Protocol documents:
Clinical trial NCT01313728
Conditions: Acne Vulgaris
Keywords: Acne Irritation
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-12-01; Completion date: 2011-01-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.

Detailed description:
This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.

Arms: arm 1: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model arm 2: Tretinoin gel applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Interventions: intervention 1: Dapsone plus Tretinoin Gel intervention 2: Tretinoin Gel
Intervention descriptions: intervention 1: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks intervention 2: Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Protocol documents:
Clinical trial NCT01319773
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2010-11-01; Completion date: 2011-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.

Detailed description:

Arms: arm 1: Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A arm 2: PGP: cyclosporine ophthalmic emulsion Formulation B arm 3: Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% arm 4: PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% arm 5: PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
Interventions: intervention 1: cyclosporine ophthalmic emulsion Formulation A intervention 2: cyclosporine ophthalmic emulsion Formulation B intervention 3: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% intervention 4: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% intervention 5: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
Intervention descriptions: intervention 1: One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3. intervention 2: One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3. intervention 3: One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day. intervention 4: One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day. intervention 5: One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.

Protocol documents:
Clinical trial NCT01332292
Conditions: Asthma
Keywords: inhalation profiles pharmacokinetics pharyngometry asthma pediatric subjects GW685698 Fluticasone furoate safety
Sponsor: GlaxoSmithKline
Start date: 2010-05-01; Completion date: 2011-01-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and serum cortisol levels.

Detailed description:
This study will investigate the effect of dosing with fluticasone furoate 100 μg (micrograms) in asthmatic subjects aged 5-11 years of age. Fluticasone furoate is currently under development as the inhaled corticosteroid component of a combination product containing an inhaled corticosteroid and a long-acting beta-agonist.

The study will be a randomized two-way crossover, with a placebo control. During each treatment period subjects will receive a daily dose via a novel dry powder inhaler for 14 days. Approximately 26 subjects will be recruited to this study, with the aim that 20 will complete the study. Safety, tolerability, pharmacokinetics and serum cortisol levels will be investigated.

Arms: arm 1: (8-11 years old) Repeat dose session: Fluticasone furoate 100µg; Day 1 and Day 14 = in house dosing; Day 2-13 = home dosing arm 2: (8-11 years old) Repeat dose session: matching placebo; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing arm 3: (5-7 years old) Repeat dose session: Fluticasone furoate 100µg; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing arm 4: (5-7 years old) Repeat dose session: Matching placebo; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing
Interventions: intervention 1: Fluticasone furoate intervention 2: Matching placebo
Intervention descriptions: intervention 1: Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate. intervention 2: Novel dry powder inhaler: One blister strip containing lactose and a second blister strip containing lactose and magnesium stearate.

Protocol documents:
Clinical trial NCT01350999
Conditions: Hypertriglyceridemia
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2009-11-01; Completion date: 2011-01-01
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Detailed description:
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.

Arms: arm 1: TAK-085 2 g, orally, once daily for up to 52 weeks. arm 2: TAK-085 2 g, orally, twice daily for up to 52 weeks. arm 3: Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
Interventions: intervention 1: omega-3-acid ethyl esters 90 (TAK-085) intervention 2: Eicosapentaenoic acid-ethyl (EPA)
Intervention descriptions: intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters. intervention 2: EPA-E capsules

Protocol documents:
Clinical trial NCT01460225
Conditions: Chronic Idiopathic Constipation
Keywords: constipation chronic idiopathic constipation no prior history of surgery to the colon not on any type of medication that could alter gastrointestinal motility or transit
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2007-09-01; Completion date: 2011-01-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.

Detailed description:

Arms: arm 1: 24 micrograms of lubiprostone twice daily for one week.
Interventions: intervention 1: lubiprostone
Intervention descriptions: intervention 1: 24 micrograms twice daily for 1 week

Protocol documents:
Clinical trial NCT01536366
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-06-01; Completion date: 2011-01-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.

Detailed description:
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers

Arms: arm 1: Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide arm 2: Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
Interventions: intervention 1: BIA 9-1067 intervention 2: Repaglinide
Intervention descriptions: intervention 1: 25 mg BIA 9-1067 (single-dose) intervention 2: 0.5 mg repaglinide (single-dose)

Protocol documents:
Clinical trial NCT01565369
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2011-01-01; Completion date: 2011-01-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.

Detailed description:

Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370MBq (10mCi), single dose

Protocol documents:
Clinical trial NCT01627860
Conditions: Epilepsy
Keywords: Epilepsy Topiramate Neuro-surgical patients Nervous disorder Seizures
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2010-02-01; Completion date: 2011-01-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.

Detailed description:
This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. The study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). After qualifying for trial entry in the retrospective baseline phase, eligible patients will be randomized in 1:1 ratio to receive either topiramate add-on therapy or topiramate monotherapy. During the titration period (period in which the dose of the study drug is increased or decreased at the discretion of investigator), topiramate, given as morning doses, will be started with daily doses of 25 mg/day for one week. After that, topiramate will be given as morning and evening doses, and the doses will be gradually increased every week to reach the initial target dose of 200 mg/day at the end of titration period. During the maintenance period, the dose of topiramate could be increased or decreased according to the investigator's judgment. Patients should keep seizure diaries during the 16 weeks of topiramate treated period and are followed with once monthly visits to the clinic, at which safety will be evaluated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Topiramate add-on therapy intervention 2: Topiramate monotherapy
Intervention descriptions: intervention 1: Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use. intervention 2: Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.

Protocol documents: