ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01202071
Conditions: Healthy
Keywords: Rabeprazole proton pump inhibitor pharmacokinetics pharmacodynamics healthy adult male Japanese subjects
Sponsor: Eisai Co., Ltd.
Start date: 2010-09-01; Completion date: 2010-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Rabeprazole sodium, 5 mg Tablets intervention 2: Rabeprazole sodium, 10 mg Tablets intervention 3: Rabeprazole sodium, 20 mg Tablets intervention 4: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
Intervention descriptions: intervention 1: Rabeprazole sodium Tablets, 5 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfast. intervention 2: Rabeprazole sodium Tablets, 10 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfast. intervention 3: Rabeprazole sodium Tablets, 20 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfast. intervention 4: Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water, \>=2 hours after the completion of breakfast.

Protocol documents:
Clinical trial NCT01205269
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease (COPD) safety inhalation long-acting muscarinic receptor antagonist (LAMA)
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2010-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Detailed description:
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

Arms: arm 1: period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo arm 2: period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg arm 3: period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg arm 4: period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo arm 5: period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg arm 6: period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
Interventions: intervention 1: AZD8683, 50 mcg intervention 2: Placebo intervention 3: AZD8683, 200 mcg
Intervention descriptions: intervention 1: Dry powder for inhalation, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Dry powder for inhalation, single dose

Protocol documents:
Clinical trial NCT01210443
Conditions: Hypertension, Pulmonary
Keywords: sitaxentan sodium pulmonary hypertension
Sponsor: Pfizer
Start date: 2010-11-01; Completion date: 2010-12-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sitaxentan
Intervention descriptions: intervention 1: sitaxentan sodium 100 mg

Protocol documents:
Clinical trial NCT01211197
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-10-01; Completion date: 2010-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

Detailed description:

Arms: arm 1: 3 treatments will be investigated in randomized order arm 2: 3 treatments will be investigated in randomized order arm 3: 3 treatments will be investigated in randomized order
Interventions: intervention 1: C: BI 10773 / metformin tablet intervention 2: B: BI 10773 tablet and metformin tablet intervention 3: A: BI 10773 / metformin tablet
Intervention descriptions: intervention 1: BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal intervention 2: BI 10773 and metformin single tablets, administered together in fasted state intervention 3: BI 10773 / metformin fixed dose combination tablet in fasted state

Protocol documents:
Clinical trial NCT01215786
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2010-10-01; Completion date: 2010-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.

Detailed description:

Arms: arm 1: AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 arm 2: timolol ophthalmic solution 0.5% arm 3: AGN-207281 vehicle ophthalmic solution (Placebo)
Interventions: intervention 1: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) intervention 2: timolol ophthalmic solution 0.5% intervention 3: AGN-207281 vehicle ophthalmic solution (Placebo)
Intervention descriptions: intervention 1: One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days. intervention 2: One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days intervention 3: One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.

Protocol documents:
Clinical trial NCT01216397
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-09-01; Completion date: 2010-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).

Detailed description:

Arms: arm 1: Fixed dose combination tablet arm 2: Fixed dose combination tablet
Interventions: intervention 1: Linagliptin/Metformin (standard batch) intervention 2: Linagliptin/Metformin (side batch)
Intervention descriptions: intervention 1: Fixed dose combination tablet intervention 2: Fixed dose combination tablet

Protocol documents:
Clinical trial NCT01218009
Conditions: Asthma
Keywords: asthma dry powder inhaler short-acting beta2-agonist SABA bronchoconstriction bronchodilation bronchodilator metered dose inhaler
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-10-01; Completion date: 2010-12-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.

Detailed description:
The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.

Arms: arm 1: Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). arm 2: Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Interventions: intervention 1: Placebo Spiromax intervention 2: Albuterol Spiromax
Intervention descriptions: intervention 1: Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime. intervention 2: Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm.

The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).

Protocol documents:
Clinical trial NCT01227187
Conditions: End Stage Renal Disease
Keywords: Hemodialysis Anticoagulation Xigris PTT
Sponsor: George Washington University
Start date: 2008-10-01; Completion date: 2010-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

Detailed description:
In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%).

Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.

Arms: arm 1: Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis.
Interventions: intervention 1: Drotrecogin alfa activated (Xigris)
Intervention descriptions: intervention 1: We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains \<65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.

Protocol documents:
Clinical trial NCT01229527
Conditions: Colonoscopy
Keywords: Colonoscopy Remifentanil Sedation
Sponsor: Ospedale San Raffaele
Start date: 2009-04-01; Completion date: 2010-12-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects.

90 patients undergoing colonoscopy will be enrolled.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Remifentanil intervention 2: Remifentanil intervention 3: Meperidine
Intervention descriptions: intervention 1: Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button. intervention 2: Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button. intervention 3: Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.

Protocol documents:
Clinical trial NCT01235195
Conditions: Healthy
Keywords: bioequivalence study sertraline 50 mg capsules vs tablets
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-11-01; Completion date: 2010-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sertraline hydrochloride intervention 2: sertraline hydrochloride
Intervention descriptions: intervention 1: 50 mg capsule, single-dose intervention 2: 50 mg tablet, single-dose

Protocol documents:
Clinical trial NCT01236105
Conditions: Insomnia
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2010-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effect of activated charcoal and dosing time on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three treatments with a washout period of at least 7 days in between treatments. Each subject will participate in all three treatments with random assignment to the treatment sequence.

Detailed description:

Arms: arm 1: Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast. arm 2: Participants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. arm 3: Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast.
Interventions: intervention 1: LY2624803 intervention 2: Activated Charcoal
Intervention descriptions: intervention 1: Administered orally (po), once. intervention 2: Administered po

Protocol documents:
Clinical trial NCT01242176
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-11-01; Completion date: 2010-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Detailed description:

Arms: arm 1: one single film-coated tablet in the morning arm 2: one single dose tablet in the morning
Interventions: intervention 1: BI 10773 XX (Trial Formulation 2) intervention 2: BI 10773 (Final Formulation)
Intervention descriptions: intervention 1: one single dose tablet in the morning intervention 2: one single film-coated tablet in the morning

Protocol documents:
Clinical trial NCT01244620
Conditions: Pulmonary Arterial Hypertension
Keywords: A pharmacokinetic drug-drug interaction study between sitaxsentan and tadalafil and between sitaxsentan and sildenafil at the steady-state
Sponsor: Pfizer
Start date: 2010-11-01; Completion date: 2010-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor).

Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.

Detailed description:

Arms: arm 1: sitaxsentan 100 mg QD for 6 days (Treatment A) arm 2: tadalafil 40 mg QD for 6 days arm 3: sitaxsentan 100 mg QD co-administered with tadalafil 40 mg QD for 6 days arm 4: sitaxsentan 100 mg QD co-administered with sildenafil 20 mg TID for 6 days
Interventions: intervention 1: sitaxentan intervention 2: tadalafil intervention 3: sitaxsentan intervention 4: tadalafil intervention 5: sitaxsentan intervention 6: sildenafil
Intervention descriptions: intervention 1: sitaxsentan 100 mg QD for 6 days intervention 2: tadalafil 40 mg QD for 6 days intervention 3: sitaxsentan 100 mg QD for 6 days intervention 4: tadalafil 40 mg QD for 6 days intervention 5: sitaxentan 100 mg QD for 6 days intervention 6: sildenafil 20 mg TID for 6 days

Protocol documents:
Clinical trial NCT01252745
Conditions: Hypogonadism
Sponsor: Acerus Pharmaceuticals Corporation
Start date: 2010-08-01; Completion date: 2010-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Detailed description:

Arms: arm 1: TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day) arm 2: TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day) arm 3: TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
Interventions: intervention 1: 10.0 mg of Testosterone, 4.0% TID intervention 2: 13.5 mg of Testosterone, 4.5% B.I.D intervention 3: 11.25 mg of Testosterone, 4.5% T.I.D
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01260883
Conditions: Postoperative Pain in Infants
Keywords: ketorolac pharmacokinetics ketorolac stereo-isomers infants postoperative analgesia safety
Sponsor: Seattle Children's Hospital
Start date: 2000-05-01; Completion date: 2010-12-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.

Detailed description:
Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months. Safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hours after drug. Morphine use between active drug groups and placebo group in the first 24 hours after surgery was assessed as a surrogate analgesic measure in these non-verbal infants. A modified infant pain scale was used to assure consistent pain management.

Arms: arm 1: ketorolac 1 mg/kg iv given by 10 min infusion arm 2: ketorolac 0.5 mg/kg iv given by 10 min infusion arm 3: placebo group received D5W 10 min infusion
Interventions: intervention 1: Ketorolac Tromethamine 1 mg/kg intervention 2: Ketorolac Tromethamine 0.5 mg/kg intervention 3: Placebo
Intervention descriptions: intervention 1: Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments. intervention 2: Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments. intervention 3: Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

Protocol documents: