Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

Viatris

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139776

A3191173

Details and patient eligibility

About

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

Enrollment: 875 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Exclusion criteria

• Subject has had surgery on index joint.
• Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
• Subject has active gastrointestinal or cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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875 participants in 2 patient groups

Celecoxib - Continuous use

Active Comparator group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

Celecoxib - Intermittent use

Active Comparator group

Treatment:

Drug: Celecoxib

Drug: Celecoxib