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

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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

Key facts

Study ID

NCT00638807

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

388

Starts

2003-12-01

Expected to finish

2004-07-01

Last updated by the study team

2021-02-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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