Clinical trial NCT00762463: Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
timeFrame: Baseline, Week 6
measure: Participant's Assessment of Global Pain Intensity at Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4
timeFrame: Baseline, Weeks 2, 4
measure: Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in BASFI at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in BASDAI at Week 12
timeFrame: Baseline, Week 12
measure: Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20
timeFrame: Weeks 2, 4, 6, 12
measure: Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in Nocturnal Pain at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in Fingertips to Floor Distance at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Chest Expansion at Weeks 2, 4, and 6
timeFrame: Baseline, Weeks 2, 4, 6
measure: Change From Baseline in Chest Expansion at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in ESR at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 6
timeFrame: Baseline, 6 Weeks
measure: Change From Baseline in CRP at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Concomitant Use of Paracetamol
timeFrame: Week 6
measure: Percentage of Days With Concomitant Administration of Paracetamol
timeFrame: Week 6
measure: Paracetamol Tablets Taken Per Day by Participant
timeFrame: Week 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Chengdu
country: China
facility: Pfizer Investigational Site
state: Sichuan
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.