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