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Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Osteoarthritis, Knee

Eligibility:

All Genders

40+ years

Phase:

PHASE4

Brief Summary

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 ibuprofe...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 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
  • 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 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2004

    Estimated Enrollment :

    380 Patients enrolled

    Trial Details

    Trial ID

    NCT00640627

    Start Date

    December 1 2003

    End Date

    September 1 2004

    Last Update

    February 2 2021

    Active Locations (30)

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    Page 1 of 8 (30 locations)

    1

    Pfizer Investigational Site

    Phoenix, Arizona, United States, 85051

    2

    Pfizer Investigational Site

    Tucson, Arizona, United States, 85712

    3

    Pfizer Investigational Site

    Long Beach, California, United States, 90806

    4

    Pfizer Investigational Site

    Paramount, California, United States, 90723