Official Title: “A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 200 mg oral capsule once daily for 12 weeks
• Drug: Celecoxib
  • 200 mg oral capsule twice daily for 12 weeks
• Drug: Diclofenac
  • 75 mg oral capsule twice daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Active Comparator: C

Primary Measures

• Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
  • Time Frame: Week 12
    Safety Issue?: No
• Responder rates, defined as 50% improvement in VAS from baseline
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• Patient's and physician's global assessment of disease activity
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Spinal pain
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Short Form-12
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Adverse events
  • Time Frame: Week 12
    Safety Issue?: Yes
• Physical evaluation
  • Time Frame: Week 12
    Safety Issue?: Yes
• Laboratory tests
  • Time Frame: Week 12
    Safety Issue?: Yes
• Nocturnal pain
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Composite Bath Ankylosing Spondylitis Disease Activity Index
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Bath Ankylosing Spondylitis Metrology Index
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Change from baseline in C-reactive protein measurement
  • Time Frame: Week 12
    Safety Issue?: No
• Responder rates, defined as 50% improvement in VAS from baseline
  • Time Frame: Weeks 1, 2, and 6
    Safety Issue?: No
• Mobility parameters
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Change from baseline in Assessments in Ankylosing Spondylitis 20 score
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No
• Change from baseline in global pain intensity
  • Time Frame: Weeks 1, 2, and 6
    Safety Issue?: No
• Bath Ankylosing Spondylitis Functional Index
  • Time Frame: Weeks 1, 2, 6, and 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648141

Study ID Number: COXA-0508-243

ClinicalTrials.gov Identifier: NCT00648141

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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