Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis
2 other identifiers
interventional
458
1 country
47
Brief Summary
To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2003
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedApril 10, 2008
March 1, 2008
March 28, 2008
April 7, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
Week 12
Responder rates, defined as 50% improvement in VAS from baseline
Week 12
Secondary Outcomes (15)
Patient's and physician's global assessment of disease activity
Weeks 1, 2, 6, and 12
Spinal pain
Weeks 1, 2, 6, and 12
Short Form-12
Weeks 1, 2, 6, and 12
Adverse events
Week 12
Physical evaluation
Week 12
- +10 more secondary outcomes
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
- Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days
You may not qualify if:
- Patients with inflammatory enterophathy, and with extra-articular manifestations
- Patients with known vertebral compression
- Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (47)
Pfizer Investigational Site
Aachen, 52064, Germany
Pfizer Investigational Site
Bad Aibling, 83043, Germany
Pfizer Investigational Site
Bad Iburg, 49186, Germany
Pfizer Investigational Site
Bad Münder am Deister, 31848, Germany
Pfizer Investigational Site
Berlin, 10559, Germany
Pfizer Investigational Site
Berlin, 10777, Germany
Pfizer Investigational Site
Berlin, 12200, Germany
Pfizer Investigational Site
Berlin, 12247, Germany
Pfizer Investigational Site
Berlin, 13125, Germany
Pfizer Investigational Site
Berlin, 14059, Germany
Pfizer Investigational Site
Berlin, D-10098, Germany
Pfizer Investigational Site
Bonn, 53179, Germany
Pfizer Investigational Site
Celle / OT Klein Hehlen, 29223, Germany
Pfizer Investigational Site
Chemnitz, 09130, Germany
Pfizer Investigational Site
Cologne, 51107, Germany
Pfizer Investigational Site
Darmstadt, 64295, Germany
Pfizer Investigational Site
Dresden, Germany
Pfizer Investigational Site
Düsseldorf, 40211, Germany
Pfizer Investigational Site
Elmshorn, 25335, Germany
Pfizer Investigational Site
Erlangen, 91056, Germany
Pfizer Investigational Site
Halle, 06128, Germany
Pfizer Investigational Site
Hanover, 30161, Germany
Pfizer Investigational Site
Heidelberg, 69120, Germany
Pfizer Investigational Site
Hildesheim, 31134, Germany
Pfizer Investigational Site
Hofheim, 65719, Germany
Pfizer Investigational Site
Hoyerswerda, 02977, Germany
Pfizer Investigational Site
Leipzig, 04107, Germany
Pfizer Investigational Site
Leverkusen, 51373, Germany
Pfizer Investigational Site
Magdeburg, 39104, Germany
Pfizer Investigational Site
Mannheim, 68165, Germany
Pfizer Investigational Site
München, 80336, Germany
Pfizer Investigational Site
Neubrandenburg, 17033, Germany
Pfizer Investigational Site
Oldenburg, 26121, Germany
Pfizer Investigational Site
Osnabrück, 49074, Germany
Pfizer Investigational Site
Pirna, 01796, Germany
Pfizer Investigational Site
Ratingen, D40882, Germany
Pfizer Investigational Site
Regensburg, Germany
Pfizer Investigational Site
Remscheid, 42897, Germany
Pfizer Investigational Site
Rheine, 48431, Germany
Pfizer Investigational Site
Rostock, 18059, Germany
Pfizer Investigational Site
Saarbrücken, 66111, Germany
Pfizer Investigational Site
Seesen, 38723, Germany
Pfizer Investigational Site
Surwold, 26903, Germany
Pfizer Investigational Site
Tübingen, 72076, Germany
Pfizer Investigational Site
Villingen-Schwenningen, 78054, Germany
Pfizer Investigational Site
Weener, 26826, Germany
Pfizer Investigational Site
Winsen, 21423, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
January 1, 2003
Study Completion
January 1, 2005
Last Updated
April 10, 2008
Record last verified: 2008-03