CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen (CI(R)CA)
Primary Purpose
Antiphospholipid Antibody Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Celecoxib
Acetaminophen
Rofecoxib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Antiphospholipid Antibody Syndrome focused on measuring Coumadin, celecoxib, rofecoxib, acetaminophen, antiphospholipid syndrome and INR
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Celecoxib
Arm Description
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.
Outcomes
Primary Outcome Measures
International Normalized Ratio
The outcome measure was verified 15 days after each intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT01762891
First Posted
September 24, 2009
Last Updated
January 6, 2013
Sponsor
Hospital Universitario Pedro Ernesto
1. Study Identification
Unique Protocol Identification Number
NCT01762891
Brief Title
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
Acronym
CI(R)CA
Official Title
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Pedro Ernesto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Antibody Syndrome
Keywords
Coumadin, celecoxib, rofecoxib, acetaminophen, antiphospholipid syndrome and INR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
celebrex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
Intervention Type
Drug
Intervention Name(s)
Rofecoxib
Other Intervention Name(s)
Vioxx
Intervention Description
Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo pills were given during 15 days by oral rout as one of the four interventions.
Primary Outcome Measure Information:
Title
International Normalized Ratio
Description
The outcome measure was verified 15 days after each intervention.
Time Frame
increase or decrease on the INR after coxibs or placebo use during 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica S Vilela, MD
Organizational Affiliation
Hospital Universitario Pedro Ernesto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
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