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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?

Arthritis, Rheumatoid

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: October 4, 2006

Completed Date: April 12, 2016

Phase: Phase 4

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT00346216