ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01333397
Conditions: Glabellar Frown Lines
Sponsor: Ipsen
Start date: 2011-03-01; Completion date: 2011-09-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Botulinum toxin type A intervention 2: Botulinum toxin type A intervention 3: Placebo
Intervention descriptions: intervention 1: I.M. (in the muscle) injection on day 1 (single treatment cycle) intervention 2: I.M. on day 1 (single treatment cycle) intervention 3: I.M. on day 1 (single treatment cycle)

Protocol documents:
Clinical trial NCT01340586
Conditions: End Stage Renal Disease
Keywords: PHARMACOKINETIC NOS
Sponsor: Bristol-Myers Squibb
Start date: 2011-06-01; Completion date: 2011-09-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.

Detailed description:
Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Apixaban intervention 2: Apixaban
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, Once, 4 days intervention 2: Tablets, Oral, 5 mg, Twice, 15 days

Protocol documents:
Clinical trial NCT01358708
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Sponsor: Forest Laboratories
Start date: 2010-06-01; Completion date: 2011-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

Detailed description:
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.

Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.

Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.

Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.

Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LACTEOL® 340 mg intervention 2: PLACEBO
Intervention descriptions: intervention 1: LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. intervention 2: Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.

Protocol documents:
Clinical trial NCT01367080
Conditions: Depression Depressive State Enuresis
Keywords: depression
Sponsor: Dong Wha Pharmaceutical Co. Ltd.
Start date: 2011-07-01; Completion date: 2011-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg

Detailed description:
Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers

Arms: arm 1: 1. 1st administration - DWETR10
2. 2nd administration - DWETR25 arm 2: 1. 1st administration - DWETR25
2. 2nd administration - DWETR10
Interventions: intervention 1: DWETR10 intervention 2: DWETR25
Intervention descriptions: intervention 1: Amitriptyline hydrochloride 10mg(DWETR10) single dose intervention 2: Amitriptyline hydrochloride 25mg(DWETR25) single dose

Protocol documents:
Clinical trial NCT01367886
Conditions: Overactive Bladder
Keywords: Urine proteomics overactive bladder
Sponsor: Washington University School of Medicine
Start date: 2010-08-01; Completion date: 2011-09-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen.

Detailed description:
The objectives of the study are:

1. to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
2. to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.

Arms: arm 1: Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.
Interventions: intervention 1: fesoterodine
Intervention descriptions: intervention 1: Fesoterodine 4 mg. tablet by mouth daily for six weeks

Protocol documents:
Clinical trial NCT01371006
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-06-01; Completion date: 2011-09-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.

To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Detailed description:

Arms: arm 1: low dose Efavirenz arm 2: normal dose Efavirenz
Interventions: intervention 1: low dose intervention 2: normal dose intervention 3: low dose
Intervention descriptions: intervention 1: efavirenz single dosing once daily intervention 2: efavirenz once daily intervention 3: Efavirenz single dosing once daily

Protocol documents:
Clinical trial NCT01372085
Conditions: Healthy Participants
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2011-09-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-centre, placebo-controlled, two-part study in healthy participants.

Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic \[effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies\] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.

Detailed description:

Arms: arm 1: A single 25 mg dose of LY2584702 RF arm 2: Placebo taken orally arm 3: A single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. arm 4: Placebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. arm 5: A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. arm 6: A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Interventions: intervention 1: LY2584702 Reference Formulation intervention 2: LY2584702 Test Formulation intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01389284
Conditions: Pain, Postoperative
Keywords: Naproxen Sodium, dental pain
Sponsor: Bayer
Start date: 2011-06-01; Completion date: 2011-09-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Detailed description:

Arms: arm 1: 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) arm 2: 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) arm 3: 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
Interventions: intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Naproxen Sodium IR (Aleve, BAYH6689) intervention 3: Naproxen Sodium ER Placebo intervention 4: Naproxen Sodium IR Placebo
Intervention descriptions: intervention 1: 660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours intervention 2: 220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours intervention 3: Matching placebo of 660 mg Naproxen Sodium ER for 24 hours intervention 4: Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours

Protocol documents:
Clinical trial NCT01391663
Conditions: Pharmacokinetics and Pharmacodynamics
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2011-07-01; Completion date: 2011-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in healthy Korean subjects.

Detailed description:
Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development Center, Inc. as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying and inhibiting glucagon secretion.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. As development of alogliptin expands to other countries, additional studies are needed to bridge between the data previously acquired.

The main objective of this study is to assess the pharmacokinetics and pharmacodynamics of alogliptin in healthy Korean participants.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days. intervention 2: Alogliptin 25 mg, tablets, orally, once daily for up to 7 days. intervention 3: Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.

Protocol documents:
Clinical trial NCT01392703
Conditions: Pharmacokinetic Study in Healthy Participants
Sponsor: Bristol-Myers Squibb
Start date: 2011-07-01; Completion date: 2011-09-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare the blood levels of dasatinib in healthy participants who received tablet formulation with those of healthy participants who received liquid and tablet-dispersed formulations of the drug.

Detailed description:

Arms: arm 1: Treatment A. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2. arm 2: Treatment B. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2. arm 3: Treatment C. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2.
Interventions: intervention 1: Dasatinib as tablets intervention 2: Dasatinib as liquid intervention 3: Dasatinib as dispersed tablets
Intervention descriptions: intervention 1: 2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day intervention 2: 100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day intervention 3: 2 50-mg dispersed tablets in 30 mL of 100% orange juice followed by 15 mL of orange juice plus 195 mL noncarbonated, nonrefrigerated water. Liquid (oral solution), single dose, 1 day.

Protocol documents:
Clinical trial NCT01398475
Conditions: Chronic Inflammatory Disorder Arthritis, Rheumatoid
Sponsor: Eli Lilly and Company
Start date: 2011-07-01; Completion date: 2011-09-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to assess the effect of 3 formulations on the relative bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4 separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK) samples will be collected during each treatment period. Approximately 5 to 7 days of washout period between each treatment and a follow-up visit will occur approximately 5 to 7 days after the last dose of study drug.

Detailed description:

Arms: arm 1: 8 milligrams (mg) LY3009104 (two 4-mg phosphate salt capsules), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. arm 2: 8 mg LY3009104 (one 8-mg smaller particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. arm 3: 8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. arm 4: 8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally with high-fat/high calorie meal, once only. There will be a washout period of 5 to 7 days between doses of study drug.
Interventions: intervention 1: LY3009104
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01401543
Conditions: Erectile Dysfunction
Keywords: testosterone energy libido erectile function weak muscles
Sponsor: Eli Lilly and Company
Start date: 2011-07-01; Completion date: 2011-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compares LY2452473 taken orally as a 5 milligram (mg) capsule at the same time as a 5 mg tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5 mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil circulating in the blood for each treatment. Side effects will be documented. This study is approximately 34 days not including screening.

Detailed description:

Arms: arm 1: 5-mg LY2452473 oral capsule and 5-mg tadalafil oral tablet, administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. arm 2: Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a smaller particle size (d90 = 10 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug.

d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. arm 3: Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with an intermediate particle size (d90 = 25 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug.

d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. arm 4: Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a larger particle size (d90 = 40 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug.

d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value.
Interventions: intervention 1: LY2452473 intervention 2: Tadalafil intervention 3: LY900010
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01404572
Conditions: HIV
Sponsor: Bristol-Myers Squibb
Start date: 2011-08-01; Completion date: 2011-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.

Detailed description:
This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Atazanavir (current formulation) intervention 2: Atazanavir, powder for oral use 1 (POU1) intervention 3: Atazanavir (POU2)
Intervention descriptions: intervention 1: Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose intervention 2: Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose intervention 3: Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose

Protocol documents:
Clinical trial NCT01441843
Conditions: Anxiety
Keywords: quality of life lorazepam anxiety premedication surgery Adult patients Ambulatory Surgical Procedures Postoperative Period
Sponsor: Erasmus Medical Center
Start date: 2010-10-01; Completion date: 2011-09-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery.

This study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting.

Detailed description:
Since the early 1980s, the investigators have seen a shift towards day-case surgery. Before surgery, many patients have negative feelings about the surgical procedure. These anxieties have various negative effects. To reduce this resistance preoperative administration of an anxiolytic drug is administered, typically a benzodiazepine. The investigators know that benzodiazepines are effective in reducing anxiety, but up to now there is nog good scientific evidence about the effectiveness of lorazepam on the quality of recovery in day-case surgery patients.

The ultimate goal of our research project is to identify patients who would benefit from preoperative benzodiazepine administration and who not. Identification would substantially contribute to optimal medical decision making.

Arms: arm 1: Lorazepam 4mg/4ml arm 2: NaCl 0.9% 4ml
Interventions: intervention 1: Lorazepam intervention 2: NaCl 0.9% (Sodium Chloride)
Intervention descriptions: intervention 1: Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery intervention 2: Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery

Protocol documents: