Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Condition(s) targeted: Spondylitis, Ankylosing

Intervention: Celecoxib (Drug); Celecoxib (Drug); Diclofenac (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for 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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change from baseline in global pain intensity as assessed by visual analog scale (VAS)

Responder rates, defined as 50% improvement in VAS from baseline

Secondary outcome:

Patient's and physician's global assessment of disease activity

Spinal pain

Short Form-12

Adverse events

Physical evaluation

Laboratory tests

Nocturnal pain

Composite Bath Ankylosing Spondylitis Disease Activity Index

Bath Ankylosing Spondylitis Metrology Index

Change from baseline in C-reactive protein measurement

Responder rates, defined as 50% improvement in VAS from baseline

Mobility parameters

Change from baseline in Assessments in Ankylosing Spondylitis 20 score

Change from baseline in global pain intensity

Bath Ankylosing Spondylitis Functional Index

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Pfizer Investigational Site, Berlin 14059, Germany

Pfizer Investigational Site, Berlin 13125, Germany

Pfizer Investigational Site, Muenchen 80336, Germany

Pfizer Investigational Site, Berlin 10559, Germany

Pfizer Investigational Site, Berlin D-10098, Germany

Pfizer Investigational Site, Ratingen D40882, Germany

Pfizer Investigational Site, Saarbruecken 66111, Germany

Pfizer Investigational Site, Berlin 12200, Germany

Pfizer Investigational Site, Hildesheim 31134, Germany

Pfizer Investigational Site, Regensburg, Germany

Pfizer Investigational Site, Tuebingen 72076, Germany

Pfizer Investigational Site, Bad Aibling 83043, Germany

Pfizer Investigational Site, Erlangen 91056, Germany

Pfizer Investigational Site, Celle / OT Klein Hehlen 29223, Germany

Pfizer Investigational Site, Rostock 18059, Germany

Pfizer Investigational Site, Koeln 51107, Germany

Pfizer Investigational Site, Leverkusen 51373, Germany

Pfizer Investigational Site, Dresden, Germany

Pfizer Investigational Site, Weener 26826, Germany

Pfizer Investigational Site, Chemnitz 09130, Germany

Pfizer Investigational Site, Bonn 53179, Germany

Pfizer Investigational Site, Mannheim 68165, Germany

Pfizer Investigational Site, Osnabrueck 49074, Germany

Pfizer Investigational Site, Oldenburg 26121, Germany

Pfizer Investigational Site, Halle 06128, Germany

Pfizer Investigational Site, Magdeburg 39104, Germany

Pfizer Investigational Site, Remscheid 42897, Germany

Pfizer Investigational Site, Neubrandenburg 17033, Germany

Pfizer Investigational Site, Hofheim 65719, Germany

Pfizer Investigational Site, Seesen 38723, Germany

Pfizer Investigational Site, Bad Muender 31848, Germany

Pfizer Investigational Site, Leipzig 04107, Germany

Pfizer Investigational Site, Rheine 48431, Germany

Pfizer Investigational Site, Villingen-Schwenningen 78054, Germany

Pfizer Investigational Site, Surwold 26903, Germany

Pfizer Investigational Site, Bad Iburg 49186, Germany

Pfizer Investigational Site, Elmshorn 25335, Germany

Pfizer Investigational Site, Winsen/Luhe 21423, Germany

Pfizer Investigational Site, Aachen 52064, Germany

Pfizer Investigational Site, Hannover 30161, Germany

Pfizer Investigational Site, Hoyerswerda 02977, Germany

Pfizer Investigational Site, Pirna 01796, Germany

Pfizer Investigational Site, Heidelberg 69120, Germany

Pfizer Investigational Site, Berlin 12247, Germany

Pfizer Investigational Site, Berlin 10777, Germany

Pfizer Investigational Site, Darmstadt 64295, Germany

Pfizer Investigational Site, Duesseldorf 40211, Germany

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: January 2003
Ending date: January 2005
Last updated: April 7, 2008