Arthritis, Rheumatoid | Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Arthritis, Rheumatoid research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms. Exclusion Criteria: - Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization; - Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial - Subjects require treatment with aspirin > 325 mg /day - Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:celecoxib100 to 200 mg twice daily, taken by mouth
Drug:Ibuprofenibuprofen 600 mg to 800 mg three times daily, taken by mouth
Drug:Naproxennaproxen 375mg to 500 mg twice daily, taken by mouth
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
celecoxibsubject receives celecoxib and dummy (placebo) ibuprofen and naproxen
ibuprofensubject receives ibuprofen and dummy (placebo) celecoxib and naproxen
naproxensubject receives naproxen and dummy (placebo) celecoxib and ibuprofen
Start Date: October 4, 2006
Completed Date: April 12, 2016
Phase: Phase 4
Primary Outcome: The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
Secondary Outcome: The First Occurrence of a Major Adverse Cardiovascular Events (MACE)
Study sponsors, principal investigator, and references
Principal Investigator: Pfizer CT.gov Call Center
Lead Sponsor: Pfizer
Collaborator: The Cleveland Clinic