Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Completed · Phase 4
Conditions studied: Arthritis, Rheumatoid
In brief
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.
Key facts
- Study ID
- NCT00346216
- Run by
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- People needed
- 24081
- Starts
- 2006-10-04
- Expected to finish
- 2016-04-12
- Last updated by the study team
- 2021-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Orthopaedics West — Bessemer, Alabama, United States
- Central Alabama Research — Birmingham, Alabama, United States
- Simon Williamson Clinic/Clinical Research Advantage, Inc. — Birmingham, Alabama, United States
- Achieve Clinical Research, LLC — Birmingham, Alabama, United States
- Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
- Cahaba Research Inc. — Birmingham, Alabama, United States
- Winston Technology Inc. — Haleyville, Alabama, United States
- Clinical Research Consultants, Inc — Hoover, Alabama, United States
- Medical Affiliated Research Center, Incorporated — Huntsville, Alabama, United States
- Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States
- Montgomery Rheumatology Associates — Montgomery, Alabama, United States
- James P. Beretta, PC — Pelham, Alabama, United States
- Alabama Clinical Research Associates — Pell City, Alabama, United States
- Pell City Internal and Family Medicine — Pell City, Alabama, United States
- Scottsboro Quick Care Clinic — Scottsboro, Alabama, United States
- Clinic for Rheumatic Diseases — Tuscaloosa, Alabama, United States
- Terence T. Hart , MD — Tuscumbia, Alabama, United States
- Clinical Research Advantage Inc./ Warner Family Practice, PC — Chandler, Arizona, United States
- ArthroCare, Arthritis Care & Research P.C. — Gilbert, Arizona, United States
- Clinical Research Advantage Inc., /Thunderbird Internal Medicine — Glendale, Arizona, United States
- Arizona Center for Clinical Research — Glendale, Arizona, United States
- Clinical Research Advantage, Inc./ Lenzmeier Family Medicine — Glendale, Arizona, United States
- Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC — Mesa, Arizona, United States
- Novara Clinical Research — Mesa, Arizona, United States
- Carol M. Johnson MD, LLC — Alabaster, Alabama, United States
Full record on ClinicalTrials.gov
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