ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01323140
Conditions: Hypogonadism
Keywords: hypogonadism, testosterone, transdermal system
Sponsor: Watson Pharmaceuticals
Start date: 2011-04-01; Completion date: 2011-07-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

Detailed description:
The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).

Arms: arm 1: Following a lead-in dose-proportionality phase (Days 1-2) and a site-to-site bioavailability phase (Days 2-9), subjects were dosed for efficacy analysis beginning on Day 9 at dose level B (a single 48 cm2 testosterone matrix transdermal system). Based on pharmacokinetic (PK) analysis of blood samples drawn on Day 16, on Day 22 subjects could be dose-titrated up to dose level C (one 28 cm2 plus one 48 cm2 TMTS), down to dose level A (one 28 cm2 TMTS), or remain at dose level B. Subjects at all dose levels were pooled for primary efficacy analysis on Days 29/30.
Interventions: intervention 1: testosterone matrix transdermal system
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01328184
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2011-07-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).

Detailed description:

Arms: arm 1: multiple doses of Microgynon arm 2: multiple doses of Microgynon + BI 10773
Interventions: intervention 1: levonorgestrel intervention 2: levonorgestrel intervention 3: Ethinylestradiol intervention 4: Microgynon + BI 10773 intervention 5: Ethinylestradiol
Intervention descriptions: intervention 1: multiple doses intervention 2: multiple doses intervention 3: multiple doses intervention 4: multiple doses BI 10773 intervention 5: multiple doses

Protocol documents:
Clinical trial NCT01330030
Conditions: Tobacco Use Disorder
Sponsor: Stanford University
Start date: 2005-07-01; Completion date: 2011-07-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.

Detailed description:
Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has interesting implications for the treatment of nicotine dependence because brain DA systems may play a key role in the mediation of reward learning behavior. Previous research suggests that the brains of living smokers show a 40% decrease in the level of MAO B relative to nonsmokers or former smokers. The purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation.

Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8 weeks. Participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. Study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine response to treatment.

Arms: arm 1: 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks arm 2: matching placebo worn 24 hours for 8 weeks
Interventions: intervention 1: Selegiline intervention 2: matching placebo
Intervention descriptions: intervention 1: 6mg/24 hrs for 8 weeks intervention 2: placebo/24hrs for 8 weeks

Protocol documents:
Clinical trial NCT01335724
Conditions: Neck Pain
Sponsor: Novartis
Start date: 2011-04-01; Completion date: 2011-07-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Diclofenac diethylamine 1.16% gel intervention 2: Placebo gel
Intervention descriptions: intervention 1: Diclofenac diethylamine 1.16% gel intervention 2: Placebo gel

Protocol documents:
Clinical trial NCT01344629
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2011-07-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use

Detailed description:
Purpose:

Arms: arm 1: single-dose, four-period replicated crossover design arm 2: single-dose, four-period replicated crossover design
Interventions: intervention 1: Telmisartan/Amlodipin FDC intervention 2: Telmisartan intervention 3: Amlodipin
Intervention descriptions: intervention 1: Telmisartan80mg/Amlodipin5mg FDC intervention 2: Telmisartan 80 mg tablet intervention 3: Amlodipin 5mg tablet

Protocol documents:
Clinical trial NCT01356407
Conditions: Colonoscopy
Sponsor: Ferring Pharmaceuticals
Start date: 2011-01-01; Completion date: 2011-07-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.

Detailed description:

Arms: arm 1: "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. arm 2: PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
Interventions: intervention 1: PICOPREP intervention 2: PEG-ELS
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01363999
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2011-06-01; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.

Detailed description:

Arms: arm 1: RO5317116/F01 bilayer tablet arm 2: RO5317116/F03 bilayer tablet arm 3: RO5317116/F04 active-coated tablet arm 4: RO4607381/F49 tablet
Interventions: intervention 1: atorvastatin intervention 2: dalcetrapib
Intervention descriptions: intervention 1: single dose of atorvastatin on day 1 intervention 2: single dose of dalcetrapib on day 1

Protocol documents:
Clinical trial NCT01365052
Conditions: Pain
Keywords: Maximum Use Safety Trial
Sponsor: Bayer
Start date: 2011-05-01; Completion date: 2011-07-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) intervention 2: Placebo
Intervention descriptions: intervention 1: 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days intervention 2: 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days

Protocol documents:
Clinical trial NCT01367262
Conditions: Healthy Volunteers
Keywords: Absorption Distribution Metabolism Excretion
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2011-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.

Detailed description:

Arms: arm 1: Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721
Interventions: intervention 1: LY2886721
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01370369
Conditions: Testicular Hypogonadism
Sponsor: Ferring Pharmaceuticals
Start date: 2011-05-01; Completion date: 2011-07-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.

Detailed description:

Arms: arm 1: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period. arm 2: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout period. arm 3: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm. arm 4: Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke) applied once daily for 10 consecutive days to the shoulder/upper arm. arm 5: Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes) applied once daily for 10 consecutive days to the shoulder/upper arm. arm 6: Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.
Interventions: intervention 1: Testosterone gel (FE 99903)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01373450
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-06-01; Completion date: 2011-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. The primary hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.

Detailed description:

Arms: arm 1: Participants received Oxyntomodulin 3.0 pmol/kg/min in the first, Liraglutide 0.6 mg in the second, Placebo in the third, and Liraglutide 1.2 mg in the fourth period arm 2: Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period arm 3: Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period arm 4: Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period arm 5: Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period arm 6: Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period
Interventions: intervention 1: Oxyntomodulin intervention 2: Liraglutide 0.6 mg intervention 3: Liraglutide 1.2 mg intervention 4: Placebo for Oxyntomodulin intervention 5: Placebo for Liraglutide
Intervention descriptions: intervention 1: 3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1) intervention 2: Single subcutaneous dose in the evening of the day before the GGI (Day-1) intervention 3: Single subcutaneous dose in the evening of the day before the GGI (Day-1) intervention 4: IV infusion in the morning of the day of GGI (Day 1) intervention 5: Single subcutaneous dose in the evening of the day before the GGI (Day-1)

Protocol documents:
Clinical trial NCT01374178
Conditions: Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2011-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.

Detailed description:

Arms: arm 1: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously. arm 2: A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
Interventions: intervention 1: LY2963016 intervention 2: Lantus
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01374802
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2011-06-01; Completion date: 2011-07-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

Detailed description:

Arms: arm 1: capsule for oral administration arm 2: tablet for oral administration arm 3: tablet for oral administration
Interventions: intervention 1: Darunavir intervention 2: Ritonavir intervention 3: BI 201335
Intervention descriptions: intervention 1: 400 mg tablet for oral administration intervention 2: tablet for oral administration intervention 3: None

Protocol documents:
Clinical trial NCT01393158
Conditions: Atopic Dermatitis
Sponsor: Oregon Health and Science University
Start date: 2009-05-01; Completion date: 2011-07-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.

Detailed description:
To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.

Arms: arm 1: Patients dosed with 20 mg orally of Apremilast BID for 3 months. arm 2: Patients dosed with 30 mg orally of Apremilast BID for 6 months.
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: 20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.

Protocol documents:
Clinical trial NCT01422382
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: Kowa Research Institute, Inc.
Start date: 2011-05-01; Completion date: 2011-07-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.

Detailed description:
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.

Arms: arm 1: There was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15
Interventions: intervention 1: Pitavastatin (NK-104) intervention 2: Diltiazem (Cardizem LA) 240 mg QD
Intervention descriptions: intervention 1: pitavastatin (NK-104) 4 mg once daily (QD) intervention 2: Diltiazem (Cardizem LA) 240 mg QD

Protocol documents:
Clinical trial NCT01447719
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2010-03-01; Completion date: 2011-07-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims:

1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
2. To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.

Detailed description:

Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.

Protocol documents:
Clinical trial NCT01609010
Conditions: Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2002-10-01; Completion date: 2011-07-01
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375 mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle of treatment. The anticipated time on study treatment is up to 6 months.

Detailed description:

Arms: arm 1: Participants received 375 milligrams per square meter (mg/m2) rituximab intravenously (i.v.) weekly for 4 weeks. Participants achieving minor response (MR), partial response (PR), or completer response (CR) received a second cycle of treatment. arm 2: Participants received 375 mg/m2 rituximab i.v. weekly for 4 weeks; and 3 million international units per day (MIU/day) interferon-a2a subcutaneously (s.c.) during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5. Interferon-a2a was not administered on days of rituximab administration. Participants achieving MR, PR, or CR received a second cycle of treatment.
Interventions: intervention 1: rituximab intervention 2: interferon-a-2a
Intervention descriptions: intervention 1: 375 mg/m2 rituximab i.v. weekly for 4 weeks intervention 2: 3 MIU/day interferon-a2a s.c. during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5

Protocol documents:
Clinical trial NCT01780389
Conditions: Knee Pain After Total Knee Arthroplasty Osteoarthritis Pain
Keywords: Knee Pain Osteoarthritis
Sponsor: Duke University
Start date: 2010-10-01; Completion date: 2011-07-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current study examines the effects of milnacipran in patients who have chronic persistent knee pain one year or longer after total knee arthroplasty (TKA) to evaluate for a pain-relieving effect.

Detailed description:
The current study proposes to collect pilot data on the utility of open-label milnacipran for the treatment of pain and other outcomes in this unfortunate group of patients with chronic persistent pain after TKA. Among marketed serotonin norepinephrine reuptake inhibitors (SNRIs), milnacipran has a unique property in that it blocks serotonin and norepinephrine reuptake equally. It is plausible that equipotent reuptake inhibition may confer greater analgesic benefit compared to other agents, and in preclinical animal models milnacipran has shown superior effects of ameliorating hyperalgesia and allodynia compared to some other antidepressant drugs. Additionally, milnacipran does not have inhibitory effects on cytochrome P (CYP) 450 enzymes, no binding affinity to neurotransmitter receptors liable to cause adverse events, and simple pharmacokinetics.

Arms: arm 1: Open-label flexibly dosed milnacipran
Interventions: intervention 1: Open-label flexibly dosed milnacipran
Intervention descriptions: intervention 1: None

Protocol documents: