Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Drug: Celecoxib; Drug: Diclofenac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00648141

A3191098

COXA-0508-243

Details and patient eligibility

About

To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis

Enrollment: 458 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
• Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days

Exclusion criteria

• Patients with inflammatory enterophathy, and with extra-articular manifestations
• Patients with known vertebral compression
• Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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458 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

B

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

C

Active Comparator group

Treatment:

Drug: Diclofenac