NCT01762891

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Hospital Universitario Pedro Ernesto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Antiphospholipid Antibody Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-07-01
• Completion: 2009-09-01
• First posted: 2013-01-08
• Last updated: 2013-01-08