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Trial record 1 of 1 for:    NCT00648141
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Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00648141
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date April 10, 2008
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • Change from baseline in global pain intensity as assessed by visual analog scale (VAS) [ Time Frame: Week 12 ]
  • Responder rates, defined as 50% improvement in VAS from baseline [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • Patient's and physician's global assessment of disease activity [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Spinal pain [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Short Form-12 [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Adverse events [ Time Frame: Week 12 ]
  • Physical evaluation [ Time Frame: Week 12 ]
  • Laboratory tests [ Time Frame: Week 12 ]
  • Nocturnal pain [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Composite Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Bath Ankylosing Spondylitis Metrology Index [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Change from baseline in C-reactive protein measurement [ Time Frame: Week 12 ]
  • Responder rates, defined as 50% improvement in VAS from baseline [ Time Frame: Weeks 1, 2, and 6 ]
  • Mobility parameters [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Change from baseline in Assessments in Ankylosing Spondylitis 20 score [ Time Frame: Weeks 1, 2, 6, and 12 ]
  • Change from baseline in global pain intensity [ Time Frame: Weeks 1, 2, and 6 ]
  • Bath Ankylosing Spondylitis Functional Index [ Time Frame: Weeks 1, 2, 6, and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Spondylitis, Ankylosing
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Experimental: B
    Intervention: Drug: Celecoxib
  • Active Comparator: C
    Intervention: Drug: Diclofenac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
458
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00648141
Other Study ID Numbers  ICMJE COXA-0508-243
A3191098
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP