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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00762463
• Date of registration: 29/09/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 240
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00762463
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Diclofenac SR

Drug: Celecoxib

Primary Outcome(s)

Participant's Assessment of Global Pain Intensity at Baseline [Time Frame: Baseline]

Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6 [Time Frame: Baseline, Week 6]

Secondary Outcome(s)

Change From Baseline in Nocturnal Pain at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 [Time Frame: Baseline, Week 12]

Percentage of Days With Concomitant Administration of Paracetamol [Time Frame: Week 6]

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in C-Reactive Protein (CRP) at Week 6 [Time Frame: Baseline, 6 Weeks]

Change From Baseline in ESR at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in BASDAI at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in BASFI at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in Chest Expansion at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 [Time Frame: Baseline, Week 12]

Paracetamol Tablets Taken Per Day by Participant [Time Frame: Week 6]

Change From Baseline in Fingertips to Floor Distance at Week 12 [Time Frame: Baseline, Week 12]

Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 [Time Frame: Weeks 2, 4, 6, 12]

Change From Baseline in CRP at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6 [Time Frame: Baseline, Week 6]

Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 [Time Frame: Baseline, Weeks 2, 4]

Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 [Time Frame: Baseline, Weeks 2, 4, 6]

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 [Time Frame: Baseline, Week 12]

Percentage of Participants With Concomitant Use of Paracetamol [Time Frame: Week 6]

Secondary ID(s)

A3191348

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00762463