CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen (CI(R)CA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01762891|
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
|Condition or disease||Intervention/treatment|
|Antiphospholipid Antibody Syndrome||Drug: Celecoxib Drug: Acetaminophen Drug: Rofecoxib Drug: placebo|
|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|
|Primary Completion Date :||July 2006|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762891
|Principal Investigator:||Veronica S Vilela, MD||Hospital Universitario Pedro Ernesto|