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

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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

Key facts

Study ID

NCT00640627

Run by

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

People needed

380

Starts

2003-12-01

Expected to finish

2004-09-01

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…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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