Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen
NCT ID: NCT00640627
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
380 participants
INTERVENTIONAL
2003-12-31
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Celecoxib
200 mg oral capsule once daily for 6 weeks
B
Placebo
Matched oral placebo for 6 weeks
Interventions
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Celecoxib
200 mg oral capsule once daily for 6 weeks
Placebo
Matched oral placebo for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Colorado Springs, Colorado, United States
Pfizer Investigational Site
Wheat Ridge, Colorado, United States
Pfizer Investigational Site
DeLand, Florida, United States
Pfizer Investigational Site
Naples, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
St. Petersburg, Florida, United States
Pfizer Investigational Site
Woodstock, Georgia, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Flowood, Mississippi, United States
Pfizer Investigational Site
Chesterfield, Missouri, United States
Pfizer Investigational Site
Reno, Nevada, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
Mason, Ohio, United States
Pfizer Investigational Site
Beaver, Pennsylvania, United States
Pfizer Investigational Site
Camp Hill, Pennsylvania, United States
Pfizer Investigational Site
Jenkintown, Pennsylvania, United States
Pfizer Investigational Site
Greensboro, South Carolina, United States
Pfizer Investigational Site
Johnson City, Tennessee, United States
Pfizer Investigational Site
Murfreesboro, Tennessee, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Seattle, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191069
Identifier Type: -
Identifier Source: org_study_id
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