Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients 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 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 co...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2004

Estimated Enrollment :

388 Patients enrolled

Trial Details

Trial ID

NCT00638807

Start Date

December 1 2003

End Date

July 1 2004

Last Update

February 2 2021

Active Locations (33)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (33 locations)

1

Pfizer Investigational Site

Birmingham, Alabama, United States, 35235

2

Pfizer Investigational Site

Buena Park, California, United States, 90620

3

Pfizer Investigational Site

Denver, Colorado, United States, 80204

4

Pfizer Investigational Site

Washington D.C., District of Columbia, United States, 20006