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

NCT00648141

Last updated date
Study Location
Pfizer Investigational Site
Aachen, , 52064, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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 CenterPfizer
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