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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Guangzhou, Guangdong, 510630 China
Contact
1-800-718-1021
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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00762463
Pfizer
Completed
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

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Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Drug: Celecoxib
    capsule, 200 mg QD, 6-12 weeks
  • Drug: Diclofenac SR
    tablet, 75 mg QD,6-12 weeks
  • Experimental: Celecoxib 200 mg QD
    Intervention: Drug: Celecoxib
  • Active Comparator: Diclofenac SR 75 mg QD
    Intervention: Drug: Diclofenac SR
Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
August 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00762463
A3191348
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the

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

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