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

Viatris

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Placebo; Drug: Celecoxib; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630929

A3191062

Details and patient eligibility

About

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Enrollment: 388 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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388 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: Ibuprofen

C

Placebo Comparator group

Treatment:

Drug: Placebo

B

Experimental group

Treatment:

Drug: Celecoxib