ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02260492
Conditions: Asthma
Sponsor: Oriel Therapeutics
Start date: 2014-09-01; Completion date: 2015-07-01
Enrollment: 879 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.

Detailed description:

Arms: arm 1: OT329 Solis (twice daily inhalation throughout the study) arm 2: Advair Diskus (twice daily inhalation throughout the study) arm 3: Placebo (twice daily inhalation throughout the study)
Interventions: intervention 1: OT329 (combination of fluticasone propionate and salmeterol xinafoate) intervention 2: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate) intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler intervention 2: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler intervention 3: Placebo (lactose) administered via the Solis dry powder inhaler

Protocol documents:
Clinical trial NCT02293538
Conditions: Refractive Error
Keywords: Symptoms of Contact Lens Related Discomfort
Sponsor: Alcon Research
Start date: 2014-11-01; Completion date: 2015-07-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.

Detailed description:

Arms: arm 1: FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. arm 2: Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
Interventions: intervention 1: FID 114657 eye drops (10 ml) intervention 2: Saline control eye drops (15 ml) intervention 3: Habitual contact lenses
Intervention descriptions: intervention 1: Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye intervention 2: Saline eye drops (15 ml) intervention 3: Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Protocol documents:
Clinical trial NCT02310646
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2015-01-01; Completion date: 2015-07-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Detailed description:
An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Arms: arm 1: Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel arm 2: Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
Interventions: intervention 1: LEO 90100 Aerosol Foam intervention 2: Daivobet® gel
Intervention descriptions: intervention 1: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week intervention 2: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.

Protocol documents:
Clinical trial NCT02353754
Conditions: Pain
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2015-05-01; Completion date: 2015-07-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).

Detailed description:
There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).

Arms: arm 1: Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. arm 2: Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
Interventions: intervention 1: Intrathecal morphine injection intervention 2: EXPAREL
Intervention descriptions: intervention 1: 0.2 mg intervention 2: 266 mg

Protocol documents:
Clinical trial NCT02370043
Conditions: Healthy Volunteers Insulin Resistance
Sponsor: Kaneq Bioscience Limited
Start date: 2015-02-01; Completion date: 2015-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels may be studied, in two distinct groups or cohorts.

Detailed description:

Arms: arm 1: Escalating doses of KQ-791, starting at 15 milligrams arm 2: Single dose of KQ-791 in capsule form, after a meal arm 3: Single dose of placebo matching KQ-791 dose
Interventions: intervention 1: KQ-791 intervention 2: KQ-791 (after meal) intervention 3: Placebo
Intervention descriptions: intervention 1: Capsules administered orally while fasting, in up to 3 periods intervention 2: Single dose of KQ-791 in capsules, after a meal, in 1 period intervention 3: Capsules, administered orally, in 1 period

Protocol documents:
Clinical trial NCT02400333
Conditions: Bioavailability Healthy Subjects
Keywords: ticagrelor orodispersible tablet ticagrelor immediate-release tablet relative bioavailability Phase I healthy subjects
Sponsor: AstraZeneca
Start date: 2015-06-01; Completion date: 2015-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD) tablets when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets

Detailed description:
Study to evaluate the bioavailability of ticagrelor OD tablets administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Arms: arm 1: Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4 arm 2: Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4 arm 3: Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4 arm 4: Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4
Interventions: intervention 1: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water intervention 2: Ticagrelor OD tablet (90 mg single dose) administered without water intervention 3: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube intervention 4: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Intervention descriptions: intervention 1: 90 mg single dose intervention 2: 90 mg single dose intervention 3: 90 mg single dose intervention 4: 90 mg single dose

Protocol documents:
Clinical trial NCT02414152
Conditions: Hearing Loss, Sudden
Sponsor: Andrea Vambutas
Start date: 2013-10-01; Completion date: 2015-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in patients with sudden sensorineural hearing loss that did not respond to oral steroid therapy. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.

The investigators will be measuring hearing thresholds (Pure tone average and word recognition scores) before and after anakinra and correlating these findings with circulating IL-1 levels in the patient's blood.

Detailed description:
For patients that experience an acute, sensorineural decline in hearing, timely corticosteroid administration may result in preservation of some or all of the hearing. For patients with sudden sensorineural hearing loss who have failed to respond to corticosteroid therapy, this study will be offered to determine if anakinra is a safe and effective alternative therapy for clinical hearing restoration. The investigators have previously demonstrated that IL-1beta inhibition (with anakinra) in a small cohort of patients with steroid resistant autoimmune inner ear disease was effective in demonstrating audiological improvements.

Arms: arm 1: 100mg of Anakinra administered as a daily subcutaneous injection
Interventions: intervention 1: anakinra
Intervention descriptions: intervention 1: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response

Protocol documents:
Clinical trial NCT02415959
Conditions: Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
Keywords: Exocrine Pancreatic Insufficiency
Sponsor: Abbott
Start date: 2015-03-01; Completion date: 2015-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).

Detailed description:
This study is a Phase II, randomized, parallel-group, active-controlled, double-blind, dose ranging, multicenter study with 4 different doses of Creon IR and one dose of the active control Creon® (DR/GR), administered in subjects of 12 years or older with PEI due to CF.

The study is divided into two periods: a screening period of 14 days and a double-blind treatment period of 6 to 7 days.

Arms: arm 1: Creon IR 300 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units) arm 2: Creon IR 1,200 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units) arm 3: Creon IR 2,400 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units) arm 4: Creon IR 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) arm 5: Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Interventions: intervention 1: Creon IR intervention 2: Creon® (DR/GR)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02442310
Conditions: Healthy
Keywords: deferiprone deferiprone delayed release formulation pharmacokinetics
Sponsor: ApoPharma
Start date: 2015-05-01; Completion date: 2015-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.

Detailed description:
This is a single-center, open-label, randomized, 4-period crossover study of the pharmacokinetics of a new formulation of deferiprone, delayed release tablets in twenty healthy volunteers. In each study period, blood samples for pharmacokinetics assessment will be collected pre-dose and over 24 hours post-dose. Safety will be assessed throughout the study.

Arms: arm 1: A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast arm 2: A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast arm 3: A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast arm 4: A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Interventions: intervention 1: Deferiprone delayed release tablet formulation intervention 2: Deferiprone oral solution
Intervention descriptions: intervention 1: Deferiprone 600 mg delayed release tablet formulation intervention 2: Deferiprone 100 mg/mL oral solution

Protocol documents:
Clinical trial NCT02481141
Conditions: Diabetes Mellitus, Type 2
Sponsor: SBI Pharmaceuticals Co, Ltd.
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes.

Detailed description:
The primary objective is to assess the safety of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes mellitus. Safety will be assessed by the incidence of adverse events and clinically significant laboratory results.

The secondary objective is to assess the efficacy of 5-ALA-SFC at doses up to 200 mg per day on glycemic control in subjects with type II diabetes mellitus. Efficacy measures will include fasting plasma glucose level, HbA1c level, lipid profile, and body weight.

Arms: arm 1: Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks arm 2: Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks
Interventions: intervention 1: 5-ALA-SFC intervention 2: Placebo
Intervention descriptions: intervention 1: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC intervention 2: None

Protocol documents:
Clinical trial NCT02490670
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-07-01; Completion date: 2015-07-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Detailed description:

Arms: arm 1: Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. arm 2: Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
Interventions: intervention 1: Cephalexin
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02596022
Conditions: Cocaine Dependence
Sponsor: New York State Psychiatric Institute
Start date: 2013-06-01; Completion date: 2015-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. Converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. Using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of CI-581a on cocaine self-administration as compared to the active control.

Detailed description:

Arms: arm 1: Administration of CI-581a followed 2 weeks later by CI-581b arm 2: Administration of CI-581b followed 2 weeks later by CI-581a
Interventions: intervention 1: CI-581a intervention 2: CI-581b
Intervention descriptions: intervention 1: a 50 minute infusion 24 hours prior to cocaine self-administration session intervention 2: a 50 minute infusion 24 hours prior to cocaine self-administration session

Protocol documents:
Clinical trial NCT02597907
Conditions: Postoperative Nausea and Vomiting
Sponsor: Kyungpook National University Hospital
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Detailed description:
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Study is performed during 24 hours after surgery.

Arms: arm 1: aprepitant 80 mg palonosetron 0.075 mg arm 2: aprepitant 80 mg ramosetron 0.3 mg
Interventions: intervention 1: aprepitant intervention 2: palonosetron intervention 3: Ramosetron
Intervention descriptions: intervention 1: aprepitant 80 mg is given to all patients before surgery intervention 2: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia intervention 3: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia

Protocol documents:
Clinical trial NCT02684396
Conditions: Healthy Volunteers
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-08-01; Completion date: 2015-07-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.

Detailed description:
This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy participants. The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TAK-648 to healthy participants.

The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated single dose.

This study measured how much of the study drug got into the blood stream and how long it took the body to get rid of it. Information about any side effects that may have occurred was also collected. This study was a randomized dose-rising study which means that the first group of research participants was assigned by chance to receive either the study drug or placebo. Placebo is a solution that looks like the study drug but has no active ingredient. The lowest dose of the study drug or placebo was given to the 1st group of participants (1st cohort) and a higher dose was given to the next group until all the doses of the study drug were tested. TAK-648 was dosed in 5 sequential cohorts with escalating doses from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohort. Doses could be adjusted based on available safety, tolerability, and pharmacokinetic (PK) data.

Approximately 40 healthy male and female participants were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study included 5 cohorts.

This single-center trial was conducted in the United States. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants were contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment.

Arms: arm 1: TAK-648 0.05 mg, solution, orally, once on Day 1. arm 2: TAK-648 0.15 mg, solution, orally, once on Day 1. arm 3: TAK-648 0.35 mg, solution, orally, once on Day 1. arm 4: TAK-648 0.7 mg, solution, orally, once on Day 1. arm 5: TAK-648 0.85 mg, solution, orally, once on Day 1. arm 6: TAK-648 placebo-matching solution, orally, once on Day 1.
Interventions: intervention 1: TAK-648 intervention 2: TAK-648 Placebo
Intervention descriptions: intervention 1: TAK-648 Solution intervention 2: TAK-648 placebo-matching solution

Protocol documents: