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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
Hospital Universitario Pedro Ernesto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 24, 2009
    Last Updated
    January 6, 2013
    Sponsor
    Hospital Universitario Pedro Ernesto
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    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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