Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid
NCT ID: NCT00603317
Last Updated: 2010-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2008-03-31
2010-03-31
Brief Summary
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The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics of warfarin among patients at steady state Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose.
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Detailed Description
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One period : seven consecutive days of amoxicillin(2g twice daily)- clavulanic acid (125 mg twice daily) association Wash out period of at least 4 weak with the return to a stable INR and warfarin dose One period : seven consecutive days of placebo twice daily
Main outcome INR delta Day7-Day
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
Order 1 : Firstly Amoxicillin-Acid clavulanic, and Secondly Placebo
Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo
Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily
2
Order 2 : Firstly Placebo, and Secondly Amoxicillin-Acid clavulanic
Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid
Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days
Interventions
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Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo
Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily
Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid
Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days
Eligibility Criteria
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Inclusion Criteria
* stable anticoagulation (3 consecutive INR in the target)
* stable dose
* no infection
* normal CRP
* age \>18 years
* normal transaminase levels
Exclusion Criteria
* penicillin allergy
* Alzheimer
* cancer
* thyroid disease
* gastro intestinal chronic disease
* frequent nausea or vomiting
* Cirrhosis
* chronic renal failure (GFR\<60 ml/min)
* frequent intake of paracetamol or NSAID
* addict to drugs or alcool
* St John's wort treatment or grapefruit juice intake
* concomitant drugs (amiodarone, cimetidine, SSRI, clofibrate, fenofibrate, diltiazem, fluconazole, itraconazole, isoniazide, voriconazole, métronidazole, miconazole , omeprazole, glucocorticoids, zileuton, ritonavir, rifampicin, carbamazepine, phenytoin, phenobarbital)
* antibiotic use during the 3 last weeks
* pregnancy
18 Years
80 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Reseach of Developpement
Principal Investigators
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Stephane MD MOULY, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Lariboisière - Service de médecine interne
Paris, , France
Countries
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Other Identifiers
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P051056
Identifier Type: -
Identifier Source: org_study_id
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