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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Veronica Silva Vilela, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier:
NCT01762891
First received: September 24, 2009
Last updated: January 6, 2013
Last verified: January 2013
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]
    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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762891

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

No publications provided

Responsible Party: Veronica Silva Vilela, Physician, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01762891     History of Changes
Other Study ID Numbers: 32323232, Pfizer
Study First Received: September 24, 2009
Last Updated: January 6, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anticoagulants
Hematologic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 10, 2014