Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen
NCT ID: NCT00638807
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
388 participants
INTERVENTIONAL
2003-12-31
2004-07-31
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 with morning meal for 6 weeks
B
Placebo
Matched oral placebo for 6 weeks
Interventions
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Celecoxib
200 mg oral capsule once daily with morning meal 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 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
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
Birmingham, Alabama, United States
Pfizer Investigational Site
Buena Park, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Longwood, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Zephyrhills, Florida, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Morton Grove, Illinois, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Wheaton, Maryland, United States
Pfizer Investigational Site
Springfield, Missouri, United States
Pfizer Investigational Site
Bozeman, Montana, United States
Pfizer Investigational Site
Trenton, New Jersey, United States
Pfizer Investigational Site
Binghamton, New York, United States
Pfizer Investigational Site
Brooklyn, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Cary, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Bismarck, North Dakota, United States
Pfizer Investigational Site
Eugene, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Johnstown, Pennsylvania, United States
Pfizer Investigational Site
Warwick, Rhode Island, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
New Tazewell, Tennessee, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Arlington, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, 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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A3191082
Identifier Type: -
Identifier Source: org_study_id
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