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Drug Interaction Between Paracetamol and Warfarin

NCT01104337 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2010-04-15

No results posted yet for this study

Summary

The objective of this study is to investigate whether paracetamol, given at therapeutic doses (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.

Conditions

Interventions

DRUG

paracetamol

Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets twice a day along with two matching placebo tablets once daily

DRUG

paracetamol

Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets three times a day

DRUG

Placebo

Treatment consisted of two matching placebo tablets three times a day.

Sponsors & Collaborators

  • Hopital Lariboisière

    lead OTHER

Principal Investigators

  • Stephane Mouly, MD, PhD · Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisière, Paris, France

  • Guy Simoneau, MD · Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisière, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-11-30
Completion
2010-02-28

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104337 on ClinicalTrials.gov