Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Key facts

Study ID

NCT00643799

Run by

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

People needed

586

Starts

2004-03-01

Expected to finish

2005-01-01

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…

• Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
• Functional Capacity Classification of I-III

You may not qualify if…

• Inflammatory arthritis or gout/pseudo-gout with an 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
• Acute joint trauma at index joint within the past 3 months with active symptoms
• 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 — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tempe, Arizona, United States
• Pfizer Investigational Site — Buena Park, California, United States
• Pfizer Investigational Site — Paramount, California, United States
• Pfizer Investigational Site — Rancho Mirage, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Zephyrhills, Florida, United States
• Pfizer Investigational Site — Rockford, Illinois, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Covington, Louisiana, United States
• Pfizer Investigational Site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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