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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
Sponsor:
Information provided by (Responsible Party):
Veronica Silva Vilela, Hospital Universitario Pedro Ernesto

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE January 8, 2013
Last Update Posted Date January 8, 2013
Study Start Date  ICMJE March 2003
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
Official Title  ICMJE CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Antiphospholipid Antibody Syndrome
Intervention  ICMJE
  • 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 Name: 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 Name: 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 Name: Vioxx
  • Drug: placebo
    Placebo pills were given during 15 days by oral rout as one of the four interventions.
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Drug: Celecoxib
  • Drug: Acetaminophen
  • Drug: Rofecoxib
  • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2013)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01762891
Other Study ID Numbers  ICMJE 32323232
Pfizer ( Other Grant/Funding Number: Pharmaceutic company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Veronica Silva Vilela, Hospital Universitario Pedro Ernesto
Study Sponsor  ICMJE Hospital Universitario Pedro Ernesto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Veronica S Vilela, MD Hospital Universitario Pedro Ernesto
PRS Account Hospital Universitario Pedro Ernesto
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP