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

NCT ID: NCT01762891

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2009-09-30

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

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.

Acetaminophen

Intervention Type: DRUG

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

Rofecoxib

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Acetaminophen

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

Intervention Type: DRUG

Rofecoxib

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

celebrex; Tylenol; Vioxx

Eligibility Criteria

Inclusion Criteria

• PAPS on contious stable dose of coumadin
• 18 years old or older
• Younger than 65 yo
• Signed informed consent.

Exclusion Criteria

• Renal failure
• Heart failure
• Symptomatic gastritis or peptic ulcer
• Elevated liver enzymes (>3 fold)
• Platelet count < 100,000.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role: lead

Responsible Party

Veronica Silva Vilela

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica S Vilela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Pedro Ernesto

Other Identifiers

Pfizer

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

32323232

Identifier Type: -

Identifier Source: org_study_id