CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen (CI(R)CA)
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| ClinicalTrials.gov Identifier: NCT01762891 |
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Recruitment Status :
Completed
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
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Sponsor:
Hospital Universitario Pedro Ernesto
Information provided by (Responsible Party):
Veronica Silva Vilela, Hospital Universitario Pedro Ernesto
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Antiphospholipid Antibody Syndrome | Drug: Celecoxib Drug: Acetaminophen Drug: Rofecoxib Drug: placebo | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| 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. |
| Study Start Date : | March 2003 |
| Actual Primary Completion Date : | July 2006 |
| Actual Study Completion Date : | September 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Antiphospholipid syndrome
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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.
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 |
| Responsible Party: | Veronica Silva Vilela, Physician, Hospital Universitario Pedro Ernesto |
| ClinicalTrials.gov Identifier: | NCT01762891 |
| Other Study ID Numbers: |
32323232 Pfizer ( Other Grant/Funding Number: Pharmaceutic company ) |
| First Posted: | January 8, 2013 Key Record Dates |
| Last Update Posted: | January 8, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Veronica Silva Vilela, Hospital Universitario Pedro Ernesto:
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Coumadin celecoxib rofecoxib acetaminophen antiphospholipid syndrome and INR |
Additional relevant MeSH terms:
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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 Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |