Clinical trial NCT00648141: Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondylitis, Ankylosing
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
timeFrame: Week 12
measure: Responder rates, defined as 50% improvement in VAS from baseline
timeFrame: Week 12
Secondary outcomes:
measure: Patient's and physician's global assessment of disease activity
timeFrame: Weeks 1, 2, 6, and 12
measure: Spinal pain
timeFrame: Weeks 1, 2, 6, and 12
measure: Short Form-12
timeFrame: Weeks 1, 2, 6, and 12
measure: Adverse events
timeFrame: Week 12
measure: Physical evaluation
timeFrame: Week 12
measure: Laboratory tests
timeFrame: Week 12
measure: Nocturnal pain
timeFrame: Weeks 1, 2, 6, and 12
measure: Composite Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: Weeks 1, 2, 6, and 12
measure: Bath Ankylosing Spondylitis Metrology Index
timeFrame: Weeks 1, 2, 6, and 12
measure: Change from baseline in C-reactive protein measurement
timeFrame: Week 12
measure: Responder rates, defined as 50% improvement in VAS from baseline
timeFrame: Weeks 1, 2, and 6
measure: Mobility parameters
timeFrame: Weeks 1, 2, 6, and 12
measure: Change from baseline in Assessments in Ankylosing Spondylitis 20 score
timeFrame: Weeks 1, 2, 6, and 12
measure: Change from baseline in global pain intensity
timeFrame: Weeks 1, 2, and 6
measure: Bath Ankylosing Spondylitis Functional Index
timeFrame: Weeks 1, 2, 6, and 12
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Pfizer Investigational Site
city: Bad Aibling
country: Germany
facility: Pfizer Investigational Site
city: Bad Iburg
country: Germany
facility: Pfizer Investigational Site
city: Bad Muender
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Celle / OT Klein Hehlen
country: Germany
facility: Pfizer Investigational Site
city: Chemnitz
country: Germany
facility: Pfizer Investigational Site
city: Darmstadt
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Elmshorn
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Hildesheim
country: Germany
facility: Pfizer Investigational Site
city: Hofheim
country: Germany
facility: Pfizer Investigational Site
city: Hoyerswerda
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Leverkusen
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Neubrandenburg
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Osnabrueck
country: Germany
facility: Pfizer Investigational Site
city: Pirna
country: Germany
facility: Pfizer Investigational Site
city: Ratingen
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Remscheid
country: Germany
facility: Pfizer Investigational Site
city: Rheine
country: Germany
facility: Pfizer Investigational Site
city: Rostock
country: Germany
facility: Pfizer Investigational Site
city: Saarbruecken
country: Germany
facility: Pfizer Investigational Site
city: Seesen
country: Germany
facility: Pfizer Investigational Site
city: Surwold
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Pfizer Investigational Site
city: Weener
country: Germany
facility: Pfizer Investigational Site
city: Winsen/Luhe
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: