Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA), Peripheral Vascular Disease, Rheumatoid Arthritis
Therapuetic Areas:Cardiology / Vascular Diseases, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2006
End Date:March 2016

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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

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.


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.
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
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3635 S. Clyde Morris Blvd
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Ashland, Oregon 97520
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9500 Euclid Avenue
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Jacksonville, Florida 32223
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