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 |
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.
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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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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