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Sponsors and Collaborators: |
Pfizer The Cleveland Clinic |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00346216 |
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid Osteoarthritis |
Drug: celecoxib Drug: Ibuprofen Drug: Naproxen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen |
Estimated Enrollment: | 20000 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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celecoxib: Experimental
subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
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Drug: celecoxib
100 to 200 mg twice daily, taken by mouth
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ibuprofen: Active Comparator
subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
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Drug: Ibuprofen
ibuprofen 600 mg to 800 mg three times daily, taken by mouth
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naproxen: Active Comparator
subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
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Drug: Naproxen
naproxen 375mg to 500 mg twice daily, taken by mouth
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191172 |
Study First Received: | June 28, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00346216 |
Health Authority: | United States: Food and Drug Administration |
Ibuprofen Naproxen Celecoxib Autoimmune Diseases Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |