Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis (CLOAK)

Viatris

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Celecoxib; Drug: Placebo; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643799

A3191152

Details and patient eligibility

About

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Enrollment: 586 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
• Functional Capacity Classification of I-III

Exclusion criteria

• Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
• Received acetaminophen within 24 hours of the baseline visit
• Acute joint trauma at index joint within the past 3 months with active symptoms
• History of gastrointestinal (GI) perforation, obstruction, or bleeding
• Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
• Received corticosteroids or hyaluronic acid within certain timeframe before study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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586 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Celecoxib

B

Active Comparator group

Treatment:

Drug: Naproxen

C

Placebo Comparator group

Treatment:

Drug: Placebo