Status:
COMPLETED
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR i...
Eligibility Criteria
Inclusion
- Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis
- With axial involvement
- Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)
- Need for daily treatment with NSAIDs during the previous 30 days before study entry
Exclusion
- Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)
- Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)
- Known vertebral compression
- Need for a corset during the study
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00762463
Start Date
July 1 2009
End Date
August 1 2010
Last Update
February 2 2021
Active Locations (5)
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1
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510630
2
Pfizer Investigational Site
Xi’an, Shanxi, China, 710032
3
Pfizer Investigational Site
Chengdu, Sichuan, China, 610041
4
Pfizer Investigational Site
Beijing, China, 100020