Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
NCT00648141
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- 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
- 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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Descriptive Information | ||||
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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 |
| |||
Study Arms ICMJE |
| |||
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 | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
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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 |