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

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NCT00648141

Last updated on October 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aachen, , 52064 Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00648141
Pfizer
Completed
Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

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Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Spondylitis, Ankylosing
  • 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
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Experimental: B
    Intervention: Drug: Celecoxib
  • Active Comparator: C
    Intervention: Drug: Diclofenac
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
458
January 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00648141
COXA-0508-243
A3191098
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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