Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - Any
Updated:12/7/2018
Start Date:December 2003
End Date:September 2004

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A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen

To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients
with knee osteoarthritis who were unresponsive to treatment with prescription strength
naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen


Inclusion criteria:

- OA of the knee in flare state at baseline visit and functional capacity class of I-III

- Failed adequate trials of both naproxen and ibuprofen (prescription strength) within
the past 5 years due to lack of efficacy, tolerability or both; duration of
prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for
each drug at the respective recommended doses if failure was due to lack of efficacy,
and for any duration if failure was due to lack of tolerability

Exclusion criteria:

- Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years
(subjects with fibrositis or fibromyalgia will not be excluded)

- Received acetaminophen within 24 hours of baseline visit

- Use of mobility assisting device for less than six weeks prior to study screening or
use of a walker

- History of gastrointestinal (GI) perforation, obstruction, or bleeding

- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study
medication

- Recieved corticosteroids or hyaluronic acid within certain timeframe before study
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Pembroke Pines, Florida 33024
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Albuquerque, New Mexico 87108
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Austin, Texas 78758
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Baltimore, Maryland 21234
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Camp Hill, Pennsylvania 17011
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Chesterfield, Missouri 63017
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Colorado Springs, Colorado 80918
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DeLand, Florida 32720
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Flowood, Mississippi 39232
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Greensboro, South Carolina 27401
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Jenkintown, Pennsylvania 19046
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Johnson City, Tennessee 37604
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Long Beach, California 90806
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Mason, Ohio 45040
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Murfreesboro, Tennessee 37130
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Naples, Florida 34102
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70121
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Overland Park, Kansas 66215
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Paramount, California 90723
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Phoenix, Arizona 85016
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Reno, Nevada 89502
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Saint Petersburg, Florida 33709
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Seattle, Washington 98166
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Tucson, Arizona 85715
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Tustin, California 92780
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Wheat Ridge, Colorado 80033
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Woodstock, Georgia 30189
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