ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02367885
Conditions: Influenza Infection
Keywords: Prevention
Sponsor: Takeda
Start date: 2015-02-01; Completion date: 2015-05-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.

Detailed description:
The drug being tested in this study is called TAK-850, that is under development as a vaccine for influenza infection. This study will evaluate the safety and immunogenicity of TAK-850 in healthy Japanese children when given as an intramuscular injection.

The study will enroll approximately 99 participants (33 per treatment group) to receive TAK-850 in open label fashion, The participants will be assigned to each treatment group as follows:

* a single intramuscular injection of TAK-850/0.5 mL in 13 to 19 years old healthy Japanese children,
* Two injections of TAK-850/0.5 mL in 3 to 12 years old healthy Japanese children,
* Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children.

The overall time to participate in this trial is 22 days (13-19 years old) or 43 days (6 months to 12 years old). Participants will make up to 2 visits (13-19 years old) or 3 visits (6 months to 12 years old) to the site.

Arms: arm 1: Single intramuscular injection of TAK-850 0.5 mL in participants aged 13-19 years arm 2: Two intramuscular injections of TAK-850 0.5 mL in participants aged 3-12 years old. arm 3: Two intramuscular injections of TAK-850 0.25 mL in participants aged 6-35 months old.
Interventions: intervention 1: TAK-850 0.5 mL injection intervention 2: TAK-850 0.25 mL injection
Intervention descriptions: intervention 1: TAK-850 injection intervention 2: TAK-850 intramuscular injection

Protocol documents:
Clinical trial NCT02372344
Conditions: Healthy
Keywords: the effect of food timing on PK the effect of food timing on Safety and Tolerability AZD0585 Japanese
Sponsor: AstraZeneca
Start date: 2015-03-01; Completion date: 2015-05-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.

Detailed description:
This study is an open-label, randomized, cross-over design with three single-dose treatment periods and a washout of at least 10 days in between each treatment visit. The study period consists of 5 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment), Visit 4 (third single-dose treatment) and Visit 5 (follow-up).

Target subject population is healthy male Japanese subjects aged 20-45 years. Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Arms: arm 1: Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered at the end of a 10-hour fast. arm 2: Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake). arm 3: Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
Interventions: intervention 1: AZD0585
Intervention descriptions: intervention 1: Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Protocol documents:
Clinical trial NCT02385084
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-03-01; Completion date: 2015-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Detailed description:

Arms: arm 1: Single oral dose of LY2409021 capsule in one of three study periods. arm 2: Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods. arm 3: Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods. arm 4: Single oral dose of LY2409021 capsule in one of two study periods. arm 5: Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.
Interventions: intervention 1: LY2409021
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02403635
Conditions: Healthy
Keywords: HSV Herpes volunteers drug-drug interaction
Sponsor: Maruho Europe Limited
Start date: 2015-04-01; Completion date: 2015-05-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the induction effect of ASP2151 on that enzyme to determine the extent of any possible drug interactions. The aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP3A4 probe substrate midazolam.

Detailed description:

Arms: arm 1: 400 mg ASP2151 followed by 7.5 mg midazolam
Interventions: intervention 1: Midazolam intervention 2: ASP2151
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02408796
Conditions: Acute Otitis Media AOMT
Keywords: Acute otitis media with tympanostomy tubes
Sponsor: Otonomy, Inc.
Start date: 2015-03-01; Completion date: 2015-05-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.

Detailed description:

Arms: arm 1: 6 mg OTO-201
Interventions: intervention 1: OTO-201
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02417844
Conditions: Prostatic Hyperplasia
Sponsor: Boehringer Ingelheim
Start date: 2015-04-01; Completion date: 2015-05-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Two tamsulosin HClformulations will be tested in fed state

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tamsulosin (Astellas) intervention 2: Tamsulosin HCL
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02472366
Conditions: Chronic Diabetic Macular Edema
Sponsor: Alimera Sciences
Start date: 2014-01-01; Completion date: 2015-05-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.

Detailed description:

Arms: arm 1: laser with or without prior history of intraocular corticosteroid therapy arm 2: laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
Interventions: intervention 1: ILUVIEN
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02495831
Conditions: Healthy
Keywords: PK study
Sponsor: Zambon SpA
Start date: 2015-05-01; Completion date: 2015-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.

Detailed description:
According to Xadago™ SmPC, safinamide may transiently inhibit BCRP, therefore a time interval of 5 h should be kept between dosing of safinamide and medicinal products that are BCRP substrates with a Tmax ≤2 h (e.g. diclofenac, pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan or glyburide).

Following a specific request of EMA CHMP, the present interaction study in healthy male and female volunteers was conducted to determine if co-administration of safinamide with a BCRP substrate alters plasma exposure of the BCRP substrate in vivo.

Diclofenac was chosen among the other BCRP substrates considering its large use in the general population. Diclofenac in fact is an important analgesic and anti-inflammatory drug, widely used for the treatment of postoperative pain, rheumatoid arthritis, and chronic pain. Consequently, diclofenac is often used in combination regimens and undesirable drug-drug interactions may occur.

Voltaren®, 50 mg soluble tablets, was selected among other possible diclofenac products because with this formulation peak concentration of diclofenamic acid is achieved at approximately 1 h, i.e. in less than 2 h.

The present interaction study was designed in agreement with the FDA Guideline on Drug Interaction studies, taking also in consideration the EMA guideline on the Investigation of drug interactions.

Arms: arm 1: Diclofenac sodium 50 mg oral tablets, single dose arm 2: Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
Interventions: intervention 1: Diclofenac sodium intervention 2: Diclofenac sodium and safinamide
Intervention descriptions: intervention 1: Diclofenac sodium 50 mg single dose intervention 2: Diclofenac 50 mg single dose and safinamide 200 mg single dose

Protocol documents:
Clinical trial NCT02530541
Conditions: Healthy
Sponsor: Medline Industries
Start date: 2014-04-01; Completion date: 2015-05-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pilot study to evaluate and compare activity of preoperative preparation with comparator

Detailed description:
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Arms: arm 1: 1 min application time arm 2: 2 min application time arm 3: Marketed CHG
Interventions: intervention 1: CHG
Intervention descriptions: intervention 1: Varied application times

Protocol documents:
Clinical trial NCT02685436
Conditions: Gastroesophageal Reflux Disease
Sponsor: Mansoura University Children Hospital
Start date: 2013-03-01; Completion date: 2015-05-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and exacerbations recurrence.

Detailed description:
Wheezy infants were tested for gastro-esophageal reflux disease using combined MII-pH, EGD, LLMI and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole for 12 weeks then re-evaluated for symptoms control and wheeze exacerbations recurrence.

Arms: arm 1: wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
Interventions: intervention 1: Omeprazole and domperidone
Intervention descriptions: intervention 1: wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s)

Protocol documents:
Clinical trial NCT02753699
Conditions: Hepatitis C
Keywords: Chronic hepatitis C
Sponsor: Debiopharm International SA
Start date: 2011-12-01; Completion date: 2015-05-01
Enrollment: 723 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

Detailed description:

Arms: arm 1: All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. arm 2: All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. arm 3: All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Interventions: intervention 1: Alisporivir
Intervention descriptions: intervention 1: Intervention of interest; follow-up after ALV-active study

Protocol documents:
Clinical trial NCT02052739
Conditions: Super-refractory Status Epilepticus
Keywords: Status Epilepticus Refractory status epilepticus Super-refractory status epilepticus SAGE-547 SAGE Sage Therapeutics
Sponsor: Sage Therapeutics
Start date: 2014-03-21; Completion date: 2015-05-03
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).

Detailed description:
This is an open-label study consisting of a screening period (1 day), 4-day treatment period (96 hours) followed by a 1-day dose taper period (24 hours), a 2-day acute follow-up period, and a 3 week extended follow-up period.

On Day 1 of treatment SRSE participants under seizure suppression or burst-suppression with a continuous intravenous (IV) anti-epileptic drug (AED) (third-line agent) were given a 1-hour IV loading infusion of SAGE-547 followed by a maintenance infusion. After 48 hours of SAGE-547 treatment, the continuous IV AED (third-line agent) was weaned while continuing SAGE-547 at the maintenance infusion for the remainder of the treatment period. After 96 hours (4 days) of therapy with SAGE-547, the dose was to be tapered and discontinued over 24 hours.

The participants would have routine continuous electroencephalogram (EEG) monitoring during the screening period, and continuing until 48 hours after SAGE-547 treatment had completed. Participants would then have follow-up examinations weekly for the next 3 weeks (Days 8, 15, 22, and 29), during which safety and functional assessments would be obtained. Apart from treatment with SAGE-547, all participants would receive the standard of care for adults in SRSE along with ongoing treatment for all underlying medical conditions.

Arms: arm 1: Participants received SAGE-547 IV loading infusion of 286.6 micrograms per kilogram per hour (μg/kg/hr) for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5. arm 2: Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
Interventions: intervention 1: SAGE-547
Intervention descriptions: intervention 1: Solution for injection for IV infusion

Protocol documents:
Clinical trial NCT02176356
Conditions: Facial Rhytides Crow's Feet Lines Glabellar Lines Nasolabial Fold
Sponsor: Allergan
Start date: 2014-06-30; Completion date: 2015-05-03
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study to evaluate patient satisfaction, aesthetic and psychological impact of combined treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).

Detailed description:

Arms: arm 1: JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: bimatoprost ophthalmic solution 0.03% intervention 3: JUVÉDERM® ULTRA XC intervention 4: JUVÉDERM® ULTRA PLUS XC intervention 5: JUVÉDERM® VOLUMA® XC
Intervention descriptions: intervention 1: onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas. intervention 2: bimatoprost ophthalmic solution 0.03% (LATISSE®) 1 drop applied to the upper eyelid at the base of eyelashes once daily in the evening for 17 weeks. intervention 3: JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator. intervention 4: JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator. intervention 5: JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.

Protocol documents:
Clinical trial NCT02068599
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis OA Arthritis pain
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2014-04-14; Completion date: 2015-05-04
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee

Detailed description:

Arms: arm 1: TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28. arm 2: TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28. arm 3: Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
Interventions: intervention 1: TV-45070 intervention 2: Placebo
Intervention descriptions: intervention 1: TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin. intervention 2: Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.

Protocol documents:
Clinical trial NCT02105454
Conditions: Hepatitis C Virus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-05-23; Completion date: 2015-05-04
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.

Detailed description:

Arms: arm 1: Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Interventions: intervention 1: Grazoprevir (GZR) intervention 2: Elbasvir (EBR) intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: 100 mg oral tablet (total daily dose) intervention 2: 10 mg oral capsule (total daily dose = 5 capsules) intervention 3: 200 mg oral capsule (total daily dose = 4-7 capsules)

Protocol documents:
Clinical trial NCT02204579
Conditions: Autosomal Dominant Hypocalcemia (ADH)
Keywords: Autosomal Dominant Hypocalcemia Hypocalcemia ADH Hypoparathyroidism
Sponsor: Shire
Start date: 2014-07-18; Completion date: 2015-05-04
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor antagonist) on activating mutations of the Calcium-sensing receptor in patients with Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary depending on measured levels of ionized calcium.

Detailed description:

Arms: arm 1: intravenous
Interventions: intervention 1: NPSP795
Intervention descriptions: intervention 1: None

Protocol documents: