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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.

Brief 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.

Detailed Summary: The CI(R)CA study included patient diagnosed with antiphospholipid syndrome in permanent use of coumadin. Eligible patients were invited to use in a prospective cross-over mode two weeks of celecoxib, rofecoxib, acetaminophen and placebo with two weeks of wash out between drugs. Their international normalized ratio (INR) were measured before and during the use of each study drug. The interaction with coumadin was evaluated according to increases or decreases on the INR after each medication.
Sponsor: Hospital Universitario Pedro Ernesto

Current Primary Outcome: International Normalized Ratio [ Time Frame: increase or decrease on the INR after coxibs or placebo use during 15 days ]

The outcome measure was verified 15 days after each intervention.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitario Pedro Ernesto

Dates:
Date Received: September 24, 2009
Date Started: March 2003
Date Completion:
Last Updated: January 6, 2013
Last Verified: January 2013