Effect of two distinct dosing regimen of acetaminophen on the anticoagulant effect of warfarin - INPAWA 2

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006416-30-FR

Enrollment

Registered

2006-12-11

Start date

2006-12-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial and venous thromboembolic disease including atrial fibrillation MedDRA version: 8.1 Level: LLT Classification code 10043565 Term: Thromboembolic event

Interventions

Trade Name: Doliprane Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults patients with a stable INR (target 2-3) treated with warfarin for at least one month - No recent paracetamol intake during the last two weeks - No recent treatement modification during the last 7 days - Who signed written information consent - In whom a 10 day follow up is possible - With at least 12g/dL hemoglobin serum level Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Who did not participate in a therapeutic trial during the month prior to the current study - Simultaneously participating to a therapeutic trial. - In whom acetaminophen is contreindicated - Presenting with severe cognitive impairement

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that acetaminophen significantly increase the anticoagulant effect of warfarin as assessed by tne INR;Secondary Objective: - Time to INR significant increase - Effect of age on these variation - Effect of drug-drug interactionon anticoagulation factors - Role of NAPQI , the acetaminophen toxic metabolite, on the clinical drug-drug interaction observed;Primary end point(s): To show that 2g per day of acetaminophen is increasing INR by at least 0,5 unit	—

Measure

Time frame

Main Objective: To demonstrate that acetaminophen significantly increase the anticoagulant effect of warfarin as assessed by tne INR;Secondary Objective: - Time to INR significant increase - Effect of age on these variation - Effect of drug-drug interactionon anticoagulation factors - Role of NAPQI , the acetaminophen toxic metabolite, on the clinical drug-drug interaction observed;Primary end point(s): To show that 2g per day of acetaminophen is increasing INR by at least 0,5 unit

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026