ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00939211
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD) efficacy safety inhalation long-acting muscarinic receptor antagonist (LAMA)
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2009-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.

Detailed description:

Arms: arm 1: 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 2: 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 3: 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 4: 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) arm 5: 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
Interventions: intervention 1: AZD9164 intervention 2: Tiotropium intervention 3: Placebo
Intervention descriptions: intervention 1: Solution for inhalation through nebulization, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Placebo

Protocol documents:
Clinical trial NCT00941304
Conditions: Dental Pain
Sponsor: BioDelivery Sciences International
Start date: 2009-08-01; Completion date: 2009-11-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.

Detailed description:

Arms: arm 1: Oxycodone 5-mg oral capsule and 2 buccal placebo films arm 2: Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule arm 3: Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule arm 4: Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule arm 5: Oral placebo capsule and 2 buccal placebo films
Interventions: intervention 1: Oxycodone intervention 2: Buprenorphine intervention 3: Placebo Film intervention 4: Placebo Capsule
Intervention descriptions: intervention 1: Single-dose of over-encapsulated oral 5-mg oxycodone capsule intervention 2: Single-dose of buprenorphine HCl buccal film intervention 3: Single-dose of placebo buccal film intervention 4: Single-dose of oral placebo capsule

Protocol documents:
Clinical trial NCT00947752
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Remitting Multiple Sclerosis (RRMS) Glatiramer Acetate (GA)
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-07-01; Completion date: 2009-11-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Glatiramer Acetate intervention 2: Experimental Glatiramer Acetate
Intervention descriptions: intervention 1: Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary. intervention 2: GA 20 mg/0.5 mL

Protocol documents:
Clinical trial NCT00964223
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Sponsor: Stiefel, a GSK Company
Start date: 2009-07-01; Completion date: 2009-11-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Detailed description:
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

Arms: arm 1: Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. arm 2: Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.
Interventions: intervention 1: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) intervention 2: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
Intervention descriptions: intervention 1: Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks. intervention 2: Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.

Protocol documents:
Clinical trial NCT00976209
Conditions: Vasomotor Rhinitis Seasonal Allergic Rhinitis
Sponsor: Bayer
Start date: 2009-08-01; Completion date: 2009-11-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250 participants will complete a questionnaire after taking one test product for 3 days followed by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days. Analysis of which product the consumer preferred, if any, and which product was more convenient, if any, will be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg intervention 2: Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
Intervention descriptions: intervention 1: Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days. intervention 2: Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.

Protocol documents:
Clinical trial NCT00976716
Conditions: Pain
Keywords: posttraumatic pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-09-01; Completion date: 2009-11-01
Enrollment: 80 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Celecoxib
Intervention descriptions: intervention 1: Day 1

* The first dose: Celecoxib 400mg
* The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed

Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)

\- Celecoxib 200mg twice daily

Protocol documents:
Clinical trial NCT00979615
Conditions: Vasomotor Rhinitis
Keywords: vasomotor rhinitis chronic non-allergic rhinitis VMR
Sponsor: Alcon Research
Start date: 2009-09-01; Completion date: 2009-11-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).

Detailed description:

Arms: arm 1: Olopatadine HCL Nasal Spray, 0.6% arm 2: Azelastine HCl Nasal Spray, 137 mcg
Interventions: intervention 1: Olopatadine HCL (Patanase) Nasal Spray, 0.6% intervention 2: Azelastine HCl (Astelin) Nasal Spray, 137 mcg
Intervention descriptions: intervention 1: 2 sprays/ nostril BID intervention 2: 2 sprays/ nostril BID

Protocol documents:
Clinical trial NCT00986401
Conditions: Healthy
Keywords: Adults
Sponsor: Allergan
Start date: 2009-10-01; Completion date: 2009-11-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the safety and tolerability of trospium chloride (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.

Detailed description:

Arms: arm 1: Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days. arm 2: Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
Interventions: intervention 1: Trospium Chloride (Sanctura XR®) intervention 2: Metformin hydrochloride (Glucophage®)
Intervention descriptions: intervention 1: extended release, 60 mg, oral daily intervention 2: immediate release, 500mg

Protocol documents:
Clinical trial NCT00988533
Conditions: Head Lice
Keywords: Head Lice Pediculus
Sponsor: Topaz Pharmaceuticals Inc
Start date: 2009-09-01; Completion date: 2009-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 0.5% Ivermectin Cream
Intervention descriptions: intervention 1: Topical 0.5% ivermectin cream applied to scalp and hair on day 1

Protocol documents:
Clinical trial NCT00995904
Conditions: Asthma
Keywords: asthmatic children
Sponsor: Allergan
Start date: 2009-09-01; Completion date: 2009-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.

Detailed description:

Arms: arm 1: Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 arm 2: Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 arm 3: Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 arm 4: Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 arm 5: Study visits were separated by 3-7 day intervals.

Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 arm 6: Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4
Interventions: intervention 1: 84ug MAP0020 intervention 2: 42ug MAP0020 intervention 3: 21ug MAP0020
Intervention descriptions: intervention 1: 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol intervention 2: 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol intervention 3: 21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Protocol documents:
Clinical trial NCT01115101
Conditions: Pain
Keywords: pain after cesarean visual analog scale oxycodon piritramid
Sponsor: Max Dieterich
Start date: 2009-07-01; Completion date: 2009-11-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.

Detailed description:
Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern.

After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to take care of the newborn. Oral analgesia in comparison offers superior patient satisfaction.

This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Oral Oxycodon intervention 2: Piritramid
Intervention descriptions: intervention 1: Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. intervention 2: Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes

Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.

Protocol documents:
Clinical trial NCT01151579
Conditions: COPD Sepsis Shock
Keywords: Tachycardia tachyarrhythmias bronchodilator therapy Critically ill patients
Sponsor: Fahim Khorfan, MD
Start date: 2008-12-01; Completion date: 2009-11-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

Detailed description:
A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.

Arms: arm 1: Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. arm 2: Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
Interventions: intervention 1: Levalbuterol intervention 2: Albuterol
Intervention descriptions: intervention 1: inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg intervention 2: Nebulized albuterol 2.5mg

Protocol documents:
Clinical trial NCT01278342
Conditions: Acromegaly
Keywords: Sandostatin LAR High Dose GH-receptor antagonist combination with dopamine-agonist acromegalic patients octreotide acetate Somavert Dostinex pegvisomant cabergoline not adequately controlled active acromegaly
Sponsor: Novartis Pharmaceuticals
Start date: 2006-09-01; Completion date: 2009-11-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

Detailed description:

Arms: arm 1: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. arm 2: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months arm 3: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows:

1. st week: 0.25 mg twice a week (0.50 mg/week)
2. nd week: 0.50 mg/week twice a week (1 mg/week)
3. rd week: 0.50 mg four times a week (2 mg/week)
4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
Interventions: intervention 1: Sandostatin LAR intervention 2: pegvisomant intervention 3: cabergoline
Intervention descriptions: intervention 1: 40 mg intramuscular (i.m.) every 28 days for 3 months intervention 2: Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months intervention 3: Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows:

1. st week: 0.25 mg twice a week (0.50 mg/week)
2. nd week: 0.50 mg/week twice a week (1 mg/week)
3. rd week: 0.50 mg four times a week (2 mg/week)
4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Protocol documents:
Clinical trial NCT01507051
Conditions: Venous Thrombosis
Keywords: Rivaroxaban Xa-Factors Warfarin Thrombosis Embolism
Sponsor: Bayer
Start date: 2008-11-01; Completion date: 2009-11-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective is to investigate the pharmacodynamics (effects of a drug product) when switching the treatment from warfarin to rivaroxaban.

84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind (Treatments A and B) design.

The first two groups (A, B) will receive warfarin for approximately one week to adjust their blood coagulation values to a specific level, i.e. to maintain an INR (international normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant treatment.

The first group (A) will receive rivaroxaban for four days, the second group (B) will take placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin but will receive rivaroxaban for four days.

Detailed description:

Arms: arm 1: Days -6 and -5: 10 mg warfarin once daily or lower depending on international normalized ratio (INR); Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily arm 2: Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily arm 3: Days 0 to 3: 20 mg rivaroxaban once daily
Interventions: intervention 1: Warfarin (Coumadin) intervention 2: Rivaroxaban (Xarelto, BAY59-7939) intervention 3: Placebo intervention 4: Vitamin K (Konakion)
Intervention descriptions: intervention 1: Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR intervention 2: Days 0 to 3: 20 mg rivaroxaban once daily intervention 3: Days 0 to 3: 1 tablet placebo, identical to active tablet intervention 4: Day 5: 10 mg vitamin K (Konakion) once daily

Protocol documents: