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

Last updated on March 11, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Inclusion criteria:

- Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional
capacity class of I-III at baseline visit

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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 the baseline visit

- Use of a 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

- Received corticosteroids or hyaluronic acid within certain timeframe before study

NCT00638807
Pfizer
Completed
Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen

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