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

Viatris

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis, Knee

Treatments

Drug: Placebo

Drug: Celecoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00640627

A3191069

Details and patient eligibility

About

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

Enrollment

380 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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