ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01235741
Conditions: Obesity
Keywords: Pramlintide Metreleptin Obesity Amylin Takeda
Sponsor: AstraZeneca
Start date: 2011-01-01; Completion date: 2011-09-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.

Detailed description:

Arms: arm 1: Pramlintide+Metreleptin arm 2: Placebo
Interventions: intervention 1: Pramlintide+Metreleptin intervention 2: Placebo
Intervention descriptions: intervention 1: Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks. intervention 2: Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.

Protocol documents:
Clinical trial NCT01243242
Conditions: ADHD
Keywords: ADHD,Adults,MG01CI,METADOXINE
Sponsor: Alcobra Ltd.
Start date: 2011-02-01; Completion date: 2011-09-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD

Detailed description:
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with ADHD.

Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment groups, 1400 mg Metadoxine (MG01CI) and Placebo. The study will consist of three periods: a screening period of up to 2 weeks, a 6-week double-blind treatment period, and a 2-week safety follow-up period. The total duration of subject participation will be \~10 weeks.

Overview of Study Visits

Screening Period:

Visit 1 - Screening/Baseline Visit (up to 14 days prior to dosing)

Treatment Period:

Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 2 days Visit 4 - Day 14 ± 2 days Visit 5 - Day 28 ± 2 days Visit 6 - Day 42 ± 2 days

Follow-up period:

Visit 7 - Day 56 ± 3 days

Arms: arm 1: Eligible subjects will be randomly assigned to receive MG01CI (1,400 mg) arm 2: Eligible subjects will be randomly assigned to receive Placebo (1,400 mg)
Interventions: intervention 1: Metadoxine (MG01CI)
Intervention descriptions: intervention 1: MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.

Protocol documents:
Clinical trial NCT01260584
Conditions: Coronary Artery Disease
Keywords: thienopyridine antiplatelet prasugrel clopidogrel
Sponsor: Daiichi Sankyo
Start date: 2010-11-01; Completion date: 2011-09-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel.

The primary hypothesis is that smoking status will influence the antiplatelet effects and active metabolite concentrations of clopidogrel but will have no impact on prasugrel's antiplatelet effects or active metabolite concentrations.

Detailed description:
Subjects will be stratified according to smoking status prior to being randomized to 1 of the 2 treatment sequences: prasugrel 10 mg daily for 10 days followed by clopidogrel 75 mg daily for 10 days or clopidogrel 75 mg daily for 10 days followed by prasugrel 10 mg daily for 10 days. There will be a 14-day Washout Period between Active Treatment Period 1 (when subjects receive the first drug of the sequence) and the second Active Treatment Period 2 (Period 3) (when subjects receive the second drug of the sequence). All subjects will remain on the same dose of aspirin from baseline throughout the study.

Arms: arm 1: Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken. arm 2: Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken. intervention 2: One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.

Protocol documents:
Clinical trial NCT01263028
Conditions: Chronic Kidney Disease Stages 3-5
Sponsor: Kaiser Permanente
Start date: 2010-08-01; Completion date: 2011-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ergocalciferol supplementation
Intervention descriptions: intervention 1: Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.

Protocol documents:
Clinical trial NCT01272193
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-01-01; Completion date: 2011-09-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs). intervention 2: Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

Protocol documents:
Clinical trial NCT01278160
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-01-01; Completion date: 2011-09-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).

Detailed description:

Arms: arm 1: After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals arm 2: After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: biphasic insulin aspart 30 intervention 3: metformin
Intervention descriptions: intervention 1: Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin. intervention 2: Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin. intervention 3: Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged

Protocol documents:
Clinical trial NCT01286558
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2011-09-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.

In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.

Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Detailed description:

Arms: arm 1: once daily arm 2: once daily
Interventions: intervention 1: 40 mg telmisartan intervention 2: 5 mg amlodipine intervention 3: 5 mg amlodipine intervention 4: 80 mg telmisartan
Intervention descriptions: intervention 1: once daily intervention 2: once daily intervention 3: once daily intervention 4: once daily

Protocol documents:
Clinical trial NCT01287065
Conditions: Asthma
Keywords: Fluticasone furoate Vilanterol Efficacy FEV1 FF/VI Inhalation powder
Sponsor: GlaxoSmithKline
Start date: 2010-10-01; Completion date: 2011-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Following screening there will be a run-in period of 14 days. There will be 3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each with a 14-21 day washout period between starting the next. Key assessments include; forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.

Detailed description:
This will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of AM and PM dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder(100/25mcg) on lung function. Twenty-four male and female patients will be enrolled in this study to ensure twenty evaluable subjects. After the screening there will be a run-in period of 14 days prior to first dose. Subjects will be dosed for 14 days (± 2 days) in each of the 3 treatment periods, with serial forced expiratory volume in one second (FEV1) measurements taken over a 24 hour period following the Day 14 PM dose in order to determine FEV1 weighted mean (0-24 hours). Peak expiratory flow (PEF) will also be monitored throughout the study, from the start of the run-in period until the end of the third treatment period. Between treatment periods there will be a washout period of 14-21 days. Safety assessments will include vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests, however, with the exception of AEs these will not constitute study endpoints. The results of the study will provide supporting information to understand the implications of time of day of dosing on the therapeutic response to the FF/VI Inhalation Powder.

Arms: arm 1: FF(100mcg)/Vilanterol(25mcg) in the morning (approx 09.00) for 14 days (± 2 days).; placebo in evening (approx 21.00) for 14 days (± 2 days). arm 2: Placebo in morning (approx 09.00) for 14 days (± 2 days); FF(100mcg)/Vilanterol(25mcg) in evening (approx 21.00) for 14 days (± 2 days). arm 3: Placebo given in morning (approx 09.00) and in evening (approx (21.00) for 14 days (± 2 days).
Interventions: intervention 1: FF(100mcg)/Vilanterol(25mcg) AM intervention 2: FF(100mcg)/Vilanterol(25mcg) PM intervention 3: Placebo AM intervention 4: Placebo PM
Intervention descriptions: intervention 1: Inhalation powder intervention 2: Inhalation powder intervention 3: Inhalation powder intervention 4: Inhalation powder

Protocol documents:
Clinical trial NCT01300923
Conditions: Fragile X Syndrome Autism Spectrum Disorders
Keywords: Fragile X Syndrome Acamprosate
Sponsor: Indiana University
Start date: 2010-08-01; Completion date: 2011-09-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also meet criteria for autistic disorder. The hypothesis of this study is that treatment with acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to assess the potential psychophysiological differences between FXS and autism spectrum disorders.

Detailed description:

Arms: arm 1: The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg. arm 2: This baseline comparison group will participated in only the psychophysiological and biomarker portion of subject characterization.
Interventions: intervention 1: Acamprosate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01316055
Conditions: Renal Insufficiency
Sponsor: Acorda Therapeutics
Start date: 2011-01-01; Completion date: 2011-09-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.

Detailed description:
Pharmacokinetics in normal, mildly renally impaired, and moderately renally impaired subjects

Arms: arm 1: Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers arm 2: Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment arm 3: Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
Interventions: intervention 1: Dalfampridine-ER
Intervention descriptions: intervention 1: 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Protocol documents:
Clinical trial NCT01318499
Conditions: Cataract
Keywords: cataract inflammation pain inflammatory cells aqueous flare
Sponsor: Alcon Research
Start date: 2011-03-01; Completion date: 2011-09-01
Enrollment: 1342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Detailed description:

Arms: arm 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery. arm 2: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery. arm 3: Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Nepafenac Ophthalmic Suspension, 0.1% intervention 3: Nepafenac Vehicle 0.3%
Intervention descriptions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery. intervention 2: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery. intervention 3: Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.

Protocol documents:
Clinical trial NCT01319929
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, knee pain, osteoarthritic knee pain
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2011-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain

Detailed description:

Arms: arm 1: 80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments. arm 2: Placebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.
Interventions: intervention 1: LY2828360 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01320553
Conditions: Allergic Conjunctivitis
Sponsor: Sun Pharma Advanced Research Company Limited
Start date: 2011-06-01; Completion date: 2011-09-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.

Detailed description:

Arms: arm 1: 1334H 0.15% eye drops will be administered in both eyes at 3 occasions arm 2: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions arm 3: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions arm 4: Placebo eye drops (solution)will be administered in both eyes at 3 occasions
Interventions: intervention 1: SPARC1102 I intervention 2: SPARC1102 II intervention 3: SPARC1102 III intervention 4: Vehicle
Intervention descriptions: intervention 1: SPARC1102 I will be administered in both eyes intervention 2: SPARC1102 II will be administered in both eyes intervention 3: SPARC1102 III will be administered in both eyes intervention 4: Vehicle will be administered in both eyes

Protocol documents:
Clinical trial NCT01330953
Conditions: Healthy Volunteers
Keywords: Anemia
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2011-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to evaluate the following in healthy participants: 1) LY2928057 safety, including any side effects possibly associated with LY2928057; 2) how the body processes LY2928057; 3) effect of LY2928057 on blood iron levels; and 4) immune system reactions to LY2928057.

Detailed description:

Arms: arm 1: Single intravenous placebo dose. arm 2: Day 1: single 30-milligram (mg) LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057. arm 3: Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. arm 4: Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. arm 5: Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
Interventions: intervention 1: Placebo intervention 2: LY2928057
Intervention descriptions: intervention 1: Single intravenous placebo dose. intervention 2: Single intravenous dose.

Protocol documents: