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

Viatris

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Ibuprofen; Drug: celecoxib; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620867

A3191063

Details and patient eligibility

About

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

Enrollment: 393 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

• 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

---

393 participants in 3 patient groups, including a placebo group

Ibuprofen

Experimental group

Treatment:

Drug: Ibuprofen

Celecoxib

Experimental group

Treatment:

Drug: celecoxib

placebo

Placebo Comparator group

Treatment:

Other: placebo