Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Celecoxib (Drug); Diclofenac SR (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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).
Clinical Details
Official title: A 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase Therapy
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: To demonstrate noninferiority of celecoxib 200 mg QD compared to diclofenac SR 75 mg QD in treatment of patients with AS, in term of pain assessment at week 6.
Secondary outcome: To compare celecoxib 200 mg QD with diclofenax SR 75 mg QD in treatment of AS, in term of disease activities, and improvement of functional capacity.To evaluate the safety and tolerability of celecoxib 200 mg QD in treatment of patients with AS.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Beijing 100853, China; Recruiting
Pfizer Investigational Site, Guangzhou, Guangdong 510630, China; Not yet recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: July 2009
Ending date: July 2010
Last updated: September 30, 2009
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