Trial | NCT01762891  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    22
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.
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 Started
Mar 31
2003
Primary Completion
Jul 31
2006
Study Completion
Sep 30
2009
Last Update
Jan 08
2013
Estimate

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.

Celecoxib Experimental

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.

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.
No Results Posted