drugset / Trial / NCT01762891

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

NCT01762891

Completed 22 enrolled Hospital Universitario Pedro Ernesto
NaSingle-groupTriple-blindTreatment

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.

Timeline

Start
2003-03
Primary completion
2006-07
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 3 g Oral
Subject Celecoxib Other / unclassified 200 mg Oral
Subject rofecoxib Small molecule 25 mg Oral