Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 in the treatment of Chinese patients with Ankylosing Spondylitis (AS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib; Diclofenac

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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