ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01660022
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: Medicines for Malaria Venture
Start date: 2012-09-01; Completion date: 2013-05-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Detailed description:
Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.

For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose).

Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).

Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.

Arms: arm 1: 100mg OZ439 single oral dose arm 2: 100mg OZ439 single oral dose + 160mg Piperaquine single oral dose arm 3: 100mg OZ439 single oral dose + 480mg Piperaquine single oral dose arm 4: 100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose arm 5: 300mg OZ439 single oral dose arm 6: 300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose arm 7: 800mg OZ439 single oral dose arm 8: 800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose arm 9: Placebo
Interventions: intervention 1: 100mg OZ439 single oral dose intervention 2: Placebo intervention 3: 300 mg OZ439 single oral dose intervention 4: 160mg Piperaquine single oral dose intervention 5: 480mg Piperaquine single oral dose intervention 6: 1440mg Piperaquine single oral dose intervention 7: 800 mg OZ439 single oral dose
Intervention descriptions: intervention 1: 100mg OZ439 oral suspension single dose intervention 2: Placebo intervention 3: 300mg OZ439 oral suspension single dose intervention 4: 160 mg Piperaquine tablet intervention 5: 480 mg Piperaquine tablet intervention 6: 1440 mg Piperaquine tablet intervention 7: 800mg OZ439 oral suspension single dose

Protocol documents:
Clinical trial NCT01660256
Conditions: Dry Eye
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2012-08-01; Completion date: 2013-05-01
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

Detailed description:

Arms: arm 1: OPC-12759 ophthalmic solution arm 2: OPC-12759 ophthalmic solution 0% arm 3: OPC-12759 ophthalmic suspension
Interventions: intervention 1: OPC-12759 intervention 2: Placebo
Intervention descriptions: intervention 1: Instillation, 4 times/day for 4 weeks intervention 2: None

Protocol documents:
Clinical trial NCT01660763
Conditions: Post Operative Pain
Sponsor: Talphera, Inc
Start date: 2012-08-01; Completion date: 2013-05-01
Enrollment: 419 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg intervention 2: Placebo Sufentanil NanoTab PCA System
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours. intervention 2: Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.

Protocol documents:
Clinical trial NCT01663233
Conditions: Essential Hypertension
Keywords: Essential hypertension High blood pressure
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-01; Completion date: 2013-05-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.

Detailed description:

Arms: arm 1: Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks. arm 2: Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
Interventions: intervention 1: LCZ696 intervention 2: Amlodipine intervention 3: Placebo
Intervention descriptions: intervention 1: LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day. intervention 2: Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day. intervention 3: Matching placebo to LCZ696

Protocol documents:
Clinical trial NCT01665599
Conditions: Adult Male Hypogonadism
Sponsor: Ferring Pharmaceuticals
Start date: 2012-07-01; Completion date: 2013-05-01
Enrollment: 180 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Detailed description:

Arms: arm 1: Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.

Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
Interventions: intervention 1: Testosterone gel (FE 999303)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01666951
Conditions: Renal Failure
Sponsor: Veloxis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2013-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Detailed description:
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.

Arms: arm 1: LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) arm 2: Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Interventions: intervention 1: LCP-Tacro tablets intervention 2: Prograf
Intervention descriptions: intervention 1: Tacrolimus intervention 2: Tacrolimus

Protocol documents:
Clinical trial NCT01670279
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder (MDD)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-07-01; Completion date: 2013-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.

Detailed description:
This is a phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose trial in 3 sequential cohorts of elderly subjects (age 70 to 85 years old) with MDD. Brexpiprazole will be administered as an adjunct treatment to the current antidepressant therapy that the subject is receiving. Total individual subject duration is expected to be no more than 119 days (a 30-day screening period, a 14-day washout period, up to 45-day in-clinic treatment period, and a 30-day follow-up after the last dose of trial medication).

Arms: arm 1: 14 day titration phase and two fixed dose phases. The first fixed dose phase is 14 days with a daily dose of 2mg brexpiprazole/placebo. The second fixed dose phase is 14 days with a daily dose of 3 mg brexpiprazole/placebo. arm 2: 14 day titration phase and a 14 day fixed dose phase a daily dose of 3mg brexpiprazole/placebo. arm 3: 21 day titration phase and a 14 day fixed dose phase a daily dose of 3mg brexpiprazole/placebo. arm 4: Placebo
Interventions: intervention 1: Brexpiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: up to 3mg oral dose once daily intervention 2: None

Protocol documents:
Clinical trial NCT01681277
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2013-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Detailed description:

Arms: arm 1: powder in the bottle for oral solution, oral administration with 240 ml water arm 2: powder in the bottle for oral solution, oral administration with 240 ml water arm 3: powder in the bottle for oral solution, oral administration with 240 ml water arm 4: powder in the bottle for oral solution, oral administration with 240 ml water
Interventions: intervention 1: BI 113608 PIB bid intervention 2: Placebo to BI 113608 PIB bid intervention 3: Placebo to BI 113608 PIB bid intervention 4: Placebo to BI 113608 PIB qd intervention 5: Placebo to BI 113608 PIB bid intervention 6: BI 113608 PIB bid intervention 7: BI 113608 PIB bid intervention 8: BI 113608 PIB qd
Intervention descriptions: intervention 1: powder for oral solution intervention 2: powder for oral solution intervention 3: powder for oral solution intervention 4: powder for oral solution intervention 5: powder for oral solution intervention 6: powder for oral solution intervention 7: powder for oral solution intervention 8: powder for oral solution

Protocol documents:
Clinical trial NCT01691534
Conditions: Pulmonary Tuberculosis
Keywords: Tuberculosis EBA PA824 pretomanid TMC207
Sponsor: Global Alliance for TB Drug Development
Start date: 2012-10-01; Completion date: 2013-05-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Detailed description:

Arms: arm 1: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazamine 100mg Days 4-14 arm 2: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 arm 3: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 arm 4: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 arm 5: pyrazinamide 1500mg Days 1-14 arm 6: Clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 arm 7: Rifafour e-275 mg dosed by weight
Interventions: intervention 1: TMC207 (J) intervention 2: PA-824 (PA) intervention 3: pyrazinamide (Z) intervention 4: clofazimine (C) intervention 5: Rifafour
Intervention descriptions: intervention 1: TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 intervention 2: PA-824 200mg Days 1-14 intervention 3: 1500mg Days 1-14 Dosed by Weight intervention 4: clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 intervention 5: Rifafour e-275 mg dosed by weight

Protocol documents:
Clinical trial NCT01697345
Conditions: Breast Cancer Vaginal Dryness Dyspareunia Sexual Health Quality of Life
Keywords: Vaginal Testosterone Vaginal atrophy Female Sexual Dysfunction Aromatase Inhibitors
Sponsor: Creighton University
Start date: 2013-02-01; Completion date: 2013-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life.

At the present time, there are no Food and Drug Administration (FDA) approved medications for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. Local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer.

The purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and sexual functioning.

Detailed description:

Arms: arm 1: Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
Interventions: intervention 1: Testosterone
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01706588
Conditions: Pain
Keywords: diclofenac, postsurgical pain, oral surgery
Sponsor: IBSA Institut Biochimique SA
Start date: 2013-01-01; Completion date: 2013-05-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Diclofenac sodium
Intervention descriptions: intervention 1: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.

Protocol documents:
Clinical trial NCT01731002
Conditions: Ocular Hypertension Open Angle Glaucoma
Keywords: Glaucoma
Sponsor: Aerie Pharmaceuticals
Start date: 2012-11-01; Completion date: 2013-05-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost

Detailed description:

Arms: arm 1: 1 drop to study eye once daily arm 2: 1 drop to study eye once daily arm 3: 1 drop to study eye once daily
Interventions: intervention 1: AR-13324 Ophthalmic Solution 0.01% intervention 2: AR-13324 Ophthalmic Solution 0.02% intervention 3: Latanoprost ophthalmic solution 0.005%
Intervention descriptions: intervention 1: Administered to study eye, once daily (QD) in the evening (PM) for 28 days intervention 2: Administered to study eye, QD in the PM for 28 days intervention 3: Administered to study eye, QD in the PM for 28 days

Protocol documents:
Clinical trial NCT01745380
Conditions: Anesthesia
Keywords: operative dental procedure
Sponsor: St. Renatus, LLC
Start date: 2013-02-01; Completion date: 2013-05-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed description:
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).

The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and \>50 years).

Arms: arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. arm 2: Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Interventions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% intervention 2: Placebo
Intervention descriptions: intervention 1: The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth intervention 2: The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.

Protocol documents:
Clinical trial NCT01746732
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2013-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones found in the blood will be measured and compared when taken alone and when taken with evaceptrapib. Each woman will participate in two study periods. Information about any side effects that may occur will also be collected.

Detailed description:

Arms: arm 1: Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods. Treatment A arm 2: Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods. Treatment B
Interventions: intervention 1: Ortho-Cyclen intervention 2: Evacetrapib
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents:
Clinical trial NCT01751984
Conditions: Hypercholesterolemia
Keywords: lipid-lowering drugs statin intolerance
Sponsor: Esperion Therapeutics, Inc.
Start date: 2012-10-04; Completion date: 2013-05-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.

Detailed description:

Arms: arm 1: ETC-1002 treatment, once daily oral arm 2: Placebo treatment, once daily oral
Interventions: intervention 1: ETC-1002 intervention 2: Placebo
Intervention descriptions: intervention 1: Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day intervention 2: Placebo once daily for 8 weeks

Protocol documents:
Clinical trial NCT01753739
Conditions: Seasonal Allergic Rhinitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-01-01; Completion date: 2013-05-01
Enrollment: 617 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.

Detailed description:

Arms: arm 1: Bepotastine besilate nasal spray, BID for 14 days. arm 2: Placebo nasal spray BID for 14 days arm 3: Bepotastine besilate nasal spray, BID for 14 days. arm 4: Bepotastine besilate nasal spray, BID for 14 days. arm 5: Bepotastine besilate nasal spray, BID for 14 days.
Interventions: intervention 1: Bepotastine besilate intervention 2: Placebo
Intervention descriptions: intervention 1: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days intervention 2: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Protocol documents: