Overview

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

Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
0
Participant gender:
All
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 could not tolerate prescription strength naproxen and ibuprofen
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Celecoxib
Ibuprofen
Naproxen
Criteria
Inclusion Criteria:

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 Criteria:

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