ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02269475
Conditions: Healthy Japanese Children Age 7 Years Through 18 Years
Keywords: Efficacy Safety Tolerability MEDI3250 Japanese children
Sponsor: AstraZeneca
Start date: 2014-10-01; Completion date: 2015-04-01
Enrollment: 1369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.

Detailed description:
This randomized, double-blind, placebo controlled, multicenter study will enrol 1008 subjects. The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 through 18 years of age that would support approval of MEDI3250 in Japan.

For children age 7 years through 18 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children age 7 years through 8 years not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

For the efficacy endpoint, data will be gathered on the incidence of laboratory-confirmed influenza-like illness in the two treatment arms. Laboratory-confirmed influenza-like illness would include cases of influenza diagnosed using culture-confirmation and/or PCR-based methods.

For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.

Subject will be randomized 2:1 to receive MEDI3250 or placebo.

Arms: arm 1: MEDI3250 Nasal Spray arm 2: Placebo Nasal spray
Interventions: intervention 1: MEDI3250 intervention 2: Placebo
Intervention descriptions: intervention 1: MEDI3250 intervention 2: Placebo

Protocol documents:
Clinical trial NCT02281136
Conditions: Keratosis, Actinic
Keywords: Actinic keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2014-12-01; Completion date: 2015-04-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.

Detailed description:

Arms: arm 1: 20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Interventions: intervention 1: Aminolevulinic Acid (ALA) intervention 2: BLU-U
Intervention descriptions: intervention 1: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light intervention 2: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2

Protocol documents:
Clinical trial NCT02286518
Conditions: Clinical Pharmacology
Sponsor: Takeda
Start date: 2014-11-01; Completion date: 2015-04-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.

Detailed description:
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.

The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.

Arms: arm 1: Orally, once only. arm 2: Orally, once arm 3: Orally, once arm 4: Orally, once arm 5: Orally, once arm 6: Orally, once arm 7: Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast arm 8: Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state arm 9: Orally, Twice daily, 10 days arm 10: Orally, Twice daily, 10 days arm 11: Orally, Twice daily, 10 days arm 12: Orally, Twice daily, 10 days arm 13: Cohort 1A, 2A, 3A: Orally, once arm 14: Cohort 5A: Orally, Twice daily, 10 days arm 15: Cohort 6A: Orally, Twice daily, 10 days
Interventions: intervention 1: TAK-114 10 mg capsule intervention 2: TAK-114 matched placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02300259
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-11-01; Completion date: 2015-04-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.

The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.

The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.

There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.

Detailed description:

Arms: arm 1: LY2623091 administered orally once on Day 1 of Period 1. arm 2: 200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2. arm 3: 20 mg simvastatin administered orally once daily on Day 1. arm 4: LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. arm 5: 5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. arm 6: LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2. arm 7: LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. arm 8: 240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2.
Interventions: intervention 1: LY2623091 intervention 2: Itraconazole intervention 3: Simvastatin intervention 4: Tadalafil intervention 5: Diltiazem
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally

Protocol documents:
Clinical trial NCT02321748
Conditions: Healthy
Keywords: HSV Herpes volunteers drug-drug interaction
Sponsor: Maruho Europe Limited
Start date: 2014-12-01; Completion date: 2015-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
CYP2C8 is involved in the metabolism of many drugs. So, it is important to assess in vivo the inhibitory effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2C8 probe substrate montelukast.

Detailed description:

Arms: arm 1: 10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151 arm 2: 10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Interventions: intervention 1: Montelukast intervention 2: ASP2151
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02322749
Conditions: Healthy Volunteers Bioequivalence or Bioavailability Study
Keywords: bioequivalence bioavailability pharmacokinetics Phase I AZD6244 cancer
Sponsor: AstraZeneca
Start date: 2015-02-01; Completion date: 2015-04-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant of selumetinib capsule are comparable, and to assess how drug levels differed in another variant of Selumetinib in Healthy Male Volunteers.

Detailed description:

Arms: arm 1: AZD6244 blue reference capsules (3 x 25 mg) administered orally arm 2: AZD6244 blue capsules (3 x 25 mg) Variant 1 (free base variant) administered orally arm 3: AZD6244 blue capsules (3 x 25 mg) Variant 2 (vitamin E polyethylene glycol succinate \[TPGS\] variant) administered orally
Interventions: intervention 1: selumetinib 75mg single dose intervention 2: selumetinib 75mg single dose intervention 3: selumetinib 75mg single dose
Intervention descriptions: intervention 1: 3 blue capsules of 25 mg given as a single dose intervention 2: 3 capsules of 25 mg given as a single dose intervention 3: 3 capsules of 25 mg given as a single dose

Protocol documents:
Clinical trial NCT02365558
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2015-04-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

There are two parts to the study. Participation in both parts will be required.

The study will last approximately 30 days, not including screening.

Detailed description:

Arms: arm 1: Single oral dose of evacetrapib administered alone on Day 1 of Period 1. arm 2: In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.

Evacetrapib will be co-administered once, orally on Day 14.
Interventions: intervention 1: Evacetrapib intervention 2: Omeprazole
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02369172
Conditions: Healthy
Keywords: Herpes volunteers drug-drug interaction
Sponsor: Maruho Europe Limited
Start date: 2015-02-01; Completion date: 2015-04-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo the effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe substrate bupropion.

Detailed description:

Arms: arm 1: 400 mg ASP2151 followed by 150 mg Bupropion
Interventions: intervention 1: Bupropion intervention 2: ASP2151
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02370615
Conditions: Japanese Healthy Adult Males
Sponsor: Takeda
Start date: 2015-02-01; Completion date: 2015-04-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese adult males.

Detailed description:
In Cohort 1, the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272 was evaluated by comparing between participants receiving TAK-272 alone and those receiving TAK-272 in combination with itraconazole. In Cohort 2, the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam was evaluated by comparing between participants receiving digoxin or midazolam alone and those receiving either of the drugs in combination with TAK-272.

Arms: arm 1: TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12. arm 2: Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
Interventions: intervention 1: TAK-272 intervention 2: Digoxin intervention 3: Itraconazole intervention 4: Midazolam
Intervention descriptions: intervention 1: TAK-272 tablet. intervention 2: Digoxin tablet. intervention 3: Itraconazole oral solution intervention 4: Midazolam syrup.

Protocol documents:
Clinical trial NCT02372097
Conditions: Healthy
Sponsor: Takeda
Start date: 2015-03-01; Completion date: 2015-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.

Detailed description:
Bioequivalence of 2 SYR-472 25 mg tablets and 1 SYR-472 50 mg tablet administered to healthy adult males will be investigated in a randomized, open-label, crossover study.

Arms: arm 1: Participants in group A will be orally administered 2 tablets of SYR-472 25 mg in period 1 and 1 tablet of SYR-472 50 mg tablet in period 2, both in a single dose under fasting conditions in the morning. arm 2: Participants in group B will be orally administered 1 tablet of SYR-472 50 mg in period 1 and 2 tablets of SYR-472 25 mg tablets in period 2, both in a single dose under fasting conditions in the morning.
Interventions: intervention 1: SYR-472
Intervention descriptions: intervention 1: SYR-472 25mg, 50mg

Protocol documents:
Clinical trial NCT02374164
Conditions: Gout
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-02-01; Completion date: 2015-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.

Detailed description:
The drug being tested in this study is called febuxostat extended- release (XR). This study is evaluating the effect of food on how febuxostat-XR moves throughout the body. This study will also look at the side effects and all safety results in people who took the study drug.

This 3-way crossover study will enroll approximately 36 participants. Eligible participants will be randomly (by chance) assigned to one of the 3 treatment sequences at 1:1:1 ratio. Sequence defines the order in which participants receive Regimens A (febuxostat XR 80 mg after a high fat meal), B (febuxostat XR 40 mg after fasting) and C (febuxostat XR 80 mg after fasting):

Sequence 1: A, B, C

Sequence 2: B, C, A

Sequence 3: C, A, B The dose in a period and the dose in the subsequent period will be separated by a minimum 7-day washout interval. This single-centre trial will be conducted in the United States.

Participants will make multiple visits to the clinic including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

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Arms: arm 1: Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast. arm 2: Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal. arm 3: Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
Interventions: intervention 1: Febuxostat XR
Intervention descriptions: intervention 1: Febuxostat XR capsules

Protocol documents:
Clinical trial NCT02379637
Conditions: Common Cold Associated With Cough
Keywords: N-acetylcysteine adults cough and cold
Sponsor: Novartis
Start date: 2015-01-01; Completion date: 2015-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.

Detailed description:

Arms: arm 1: N-acetylcysteine arm 2: Placebo
Interventions: intervention 1: N-acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02394340
Conditions: Tinea Pedis Tinea Cruris
Sponsor: Bausch & Lomb Incorporated
Start date: 2015-02-03; Completion date: 2015-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.

Detailed description:

Arms: arm 1: Participants will receive 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants will also receive luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
Interventions: intervention 1: Omeprazole 40 mg intervention 2: Luliconazole Cream 1%
Intervention descriptions: intervention 1: Oral capsule to be taken as per the instructions regarding proper dosing technique. intervention 2: Topical cream to be applied as per the instructions regarding proper study drug application technique.

Protocol documents:
Clinical trial NCT02413918
Conditions: Bipolar Disorder
Keywords: mixed episode
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2012-04-01; Completion date: 2015-04-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
2. To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS

Detailed description:
This is a prospective 20-week, open-label study of iloperidone added to ongoing treatment regimen with mood stabilizers (Li or DIV or LAM or any combination of these) in the acute and maintenance treatment of MS- Total number of subjects: 40.

Severity of the illness and psychopathological features will be measured by the following rating scales: YMRS, MADRS, CGI-S and GAS, and the BISS .

The study will monitor the safety and tolerability of the combination iloperidone plus mood stabilizers.

Efficacy Measures: Primary efficacy measures include 1) Mixed effects repeat measure of change from baseline in BISS total score and, secondarily, manic and depression subscale scores.

Secondary Efficacy Measures: 1) response defined as 50% reduction in YMRS and MADRS and 2) Time to intervention or discontinuation for any mood episode.

Iloperidone will be initiated at 2 mg at hs on day 1 with increase to 4mg at hs on day 2, 8 mg at hs on day 3. All patients will have iloperidone titrated to receive a dosage of at least 12 mg a day. Dosages can be titrated up to 24 mg a day based on tolerability and clinical indication. Dosage of iloperidone can be reduced to 6 mg a day if patients develop side effects necessitating a reduction in the dosage

Arms: arm 1: open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
Interventions: intervention 1: iloperidone
Intervention descriptions: intervention 1: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.

Protocol documents:
Clinical trial NCT02447497
Conditions: Bacterial Recovery of Skin Flora Post-Product Application
Sponsor: Solventum US LLC
Start date: 2015-03-01; Completion date: 2015-04-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description:
The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

Arms: arm 1: Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. arm 2: Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. arm 3: Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. arm 4: Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.
Interventions: intervention 1: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region intervention 2: Normal Saline - Abdominal Region intervention 3: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region intervention 4: Normal Saline - Inguinal Region
Intervention descriptions: intervention 1: Chlorhexidine gluconate 2% / Isopropyl alcohol 70% intervention 2: 0.9% sodium chloride applied with foam applicator intervention 3: Chlorhexidine gluconate 2% / Isopropyl alcohol 70% intervention 4: 0.9% sodium chloride applied with foam applicator

Protocol documents: