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CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen

NCT01762891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-01-08

No results posted yet for this study

Summary

Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding. New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and inflamation in these patients once interactions with coumadin are supposed to be lower. The CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and placebo.

Conditions

  • Antiphospholipid Antibody Syndrome

Interventions

DRUG

Celecoxib

celecoxib 200mg/day by oral rout during 15 days followed by the administration of rofecoxib 25mg/day, acetaminophen 3g/day and placebo during 15 days each drug.

DRUG

Acetaminophen

Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.

DRUG

Rofecoxib

Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.

DRUG

placebo

Placebo pills were given during 15 days by oral rout as one of the four interventions.

Sponsors & Collaborators

  • Hospital Universitario Pedro Ernesto

    lead OTHER

Principal Investigators

  • Veronica S Vilela, MD · Hospital Universitario Pedro Ernesto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-07-31
Completion
2009-09-30

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Entities

Drugs

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 NCT01762891 on ClinicalTrials.gov