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

Antiphospholipid Antibody Syndrome Clinical Trial

— CI(R)CA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762891
• Other study ID #: 32323232
• Secondary ID: Pfizer
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: January 6, 2013
• Start date: March 2003
• Est. completion date: September 2009

Study information

• Verified date: January 2013
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2009
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antiphospholipid Antibody Syndrome
• Antiphospholipid Syndrome

Intervention

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.
• Acetaminophen
Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
• Rofecoxib
Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
• placebo
Placebo pills were given during 15 days by oral rout as one of the four interventions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Normalized Ratio	The outcome measure was verified 15 days after each intervention.	increase or decrease on the INR after coxibs or placebo use during 15 days	Yes