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

Sponsor

Hospital Universitario Pedro Ernesto (Other)

Overall Status

Completed

CT.gov ID

NCT01762891

Collaborator

(none)

Enrollment

Arm

78.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antiphospholipid Antibody Syndrome	Drug: Celecoxib Drug: Acetaminophen Drug: Rofecoxib Drug: placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celecoxib Celecoxib 200mg/day oral rout Intervention: celecoxib 200mg oral rout administered durng 15 days and followed by administration of rofecoxib 25mg/day during 15 days, placebo 15 days and acetaminophen 3g/day during 15 days.	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. Other Names: celebrex Drug: Acetaminophen Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention. Other Names: Tylenol Drug: Rofecoxib Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention. Other Names: Vioxx Drug: placebo Placebo pills were given during 15 days by oral rout as one of the four interventions.

Arm

Intervention/Treatment

Experimental: Celecoxib

Celecoxib 200mg/day oral rout Intervention: celecoxib 200mg oral rout administered durng 15 days and followed by administration of rofecoxib 25mg/day during 15 days, placebo 15 days and acetaminophen 3g/day during 15 days.

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.

Other Names:

celebrex

Drug: Acetaminophen

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

Other Names:

Tylenol

Drug: Rofecoxib

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

Other Names:

Vioxx

Drug: placebo

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

Outcome Measures

Primary Outcome Measures

International Normalized Ratio [increase or decrease on the INR after coxibs or placebo use during 15 days]
The outcome measure was verified 15 days after each intervention.