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
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
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148 E. Hersey St.
Ashland, Oregon 97520
541-488-9325
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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Gainesville, Florida 32610
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404 Memorial Dr.
Greer, South Carolina 29651
864-848-9293
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
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750 Highland Avenue
Madison, Wisconsin 53792
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Marietta, Georgia 30060
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New London, Connecticut 06320
860-443-4567
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6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
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100 West Gore St # 202
Orlando, Florida 32806
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Pembroke Pines, Florida 33026
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San Antonio, Texas 78205
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