Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
- Registration Number
- NCT00648141
- Lead Sponsor
- Pfizer
- Brief Summary
To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Celecoxib - C Diclofenac - B Celecoxib -
- Primary Outcome Measures
Name Time Method Change from baseline in global pain intensity as assessed by visual analog scale (VAS) Week 12 Responder rates, defined as 50% improvement in VAS from baseline Week 12
- Secondary Outcome Measures
Name Time Method Patient's and physician's global assessment of disease activity Weeks 1, 2, 6, and 12 Spinal pain Weeks 1, 2, 6, and 12 Short Form-12 Weeks 1, 2, 6, and 12 Adverse events Week 12 Physical evaluation Week 12 Laboratory tests Week 12 Nocturnal pain Weeks 1, 2, 6, and 12 Composite Bath Ankylosing Spondylitis Disease Activity Index Weeks 1, 2, 6, and 12 Bath Ankylosing Spondylitis Metrology Index Weeks 1, 2, 6, and 12 Change from baseline in C-reactive protein measurement Week 12 Responder rates, defined as 50% improvement in VAS from baseline Weeks 1, 2, and 6 Mobility parameters Weeks 1, 2, 6, and 12 Change from baseline in Assessments in Ankylosing Spondylitis 20 score Weeks 1, 2, 6, and 12 Change from baseline in global pain intensity Weeks 1, 2, and 6 Bath Ankylosing Spondylitis Functional Index Weeks 1, 2, 6, and 12
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇩🇪Winsen/Luhe, Germany