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CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen (CI(R)CA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762891
First Posted: January 8, 2013
Last Update Posted: January 8, 2013
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.
Information provided by (Responsible Party):
Veronica Silva Vilela, Hospital Universitario Pedro Ernesto
  Purpose
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.

Condition Intervention
Antiphospholipid Antibody Syndrome Drug: Celecoxib Drug: Acetaminophen Drug: Rofecoxib Drug: placebo

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.

Resource links provided by NLM:


Further study details as provided by Veronica Silva Vilela, Hospital Universitario Pedro Ernesto:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: March 2003
Study Completion Date: September 2009
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Investigators
Principal Investigator: Veronica S Vilela, MD Hospital Universitario Pedro Ernesto
  More Information

Responsible Party: Veronica Silva Vilela, Physician, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01762891     History of Changes
Other Study ID Numbers: 32323232
Pfizer ( Other Grant/Funding Number: Pharmaceutic company )
First Submitted: September 24, 2009
First Posted: January 8, 2013
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Veronica Silva Vilela, Hospital Universitario Pedro Ernesto:
Coumadin
celecoxib
rofecoxib
acetaminophen
antiphospholipid syndrome and INR

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Acetaminophen
Celecoxib
Rofecoxib
Warfarin
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Anticoagulants