CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen (CI(R)CA)
|ClinicalTrials.gov Identifier: NCT01762891|
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Antibody Syndrome||Drug: Celecoxib Drug: Acetaminophen Drug: Rofecoxib Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||September 2009|
U.S. FDA Resources
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.
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 Name: celebrexDrug: Acetaminophen
Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
Other Name: TylenolDrug: Rofecoxib
Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
Other Name: VioxxDrug: placebo
Placebo pills were given during 15 days by oral rout as one of the four interventions.
- International Normalized Ratio [ Time Frame: increase or decrease on the INR after coxibs or placebo use during 15 days ]The outcome measure was verified 15 days after each intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762891
|Principal Investigator:||Veronica S Vilela, MD||Hospital Universitario Pedro Ernesto|