Overview

Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
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
Criteria
Inclusion Criteria:

Inclusion criteria:

- Aged >=40 years old

- Diagnosed with OA of the knee according to the American College of Rheumatology and OA
in flare state at baseline visit

- Functional capacity class of I-III

Exclusion Criteria:

Exclusion criteria:

- Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years
(subjects with fibrositis or fibromyalgia will not be excluded)

- Acute joint trauma at index joint within the past 3 months with active symptoms

- Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i

- Use of mobility assisting device for <6 weeks or use of walker