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

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

Study Overview

• Status: Completed
• Conditions: Spondylitis, Ankylosing
• Intervention / Treatment: Drug: Celecoxib; Drug: Celecoxib; Drug: Diclofenac

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52064
    • Pfizer Investigational Site
  • Bad Aibling, Germany, 83043
    • Pfizer Investigational Site
  • Bad Iburg, Germany, 49186
    • Pfizer Investigational Site
  • Bad Muender, Germany, 31848
    • Pfizer Investigational Site
  • Berlin, Germany, 12200
    • Pfizer Investigational Site
  • Berlin, Germany, 14059
    • Pfizer Investigational Site
  • Berlin, Germany, 13125
    • Pfizer Investigational Site
  • Berlin, Germany, 10559
    • Pfizer Investigational Site
  • Berlin, Germany, 10777
    • Pfizer Investigational Site
  • Berlin, Germany, 12247
    • Pfizer Investigational Site
  • Berlin, Germany, D-10098
    • Pfizer Investigational Site
  • Bonn, Germany, 53179
    • Pfizer Investigational Site
  • Celle / OT Klein Hehlen, Germany, 29223
    • Pfizer Investigational Site
  • Chemnitz, Germany, 09130
    • Pfizer Investigational Site
  • Darmstadt, Germany, 64295
    • Pfizer Investigational Site
  • Dresden, Germany
    • Pfizer Investigational Site
  • Duesseldorf, Germany, 40211
    • Pfizer Investigational Site
  • Elmshorn, Germany, 25335
    • Pfizer Investigational Site
  • Erlangen, Germany, 91056
    • Pfizer Investigational Site
  • Halle, Germany, 06128
    • Pfizer Investigational Site
  • Hannover, Germany, 30161
    • Pfizer Investigational Site
  • Heidelberg, Germany, 69120
    • Pfizer Investigational Site
  • Hildesheim, Germany, 31134
    • Pfizer Investigational Site
  • Hofheim, Germany, 65719
    • Pfizer Investigational Site
  • Hoyerswerda, Germany, 02977
    • Pfizer Investigational Site
  • Koeln, Germany, 51107
    • Pfizer Investigational Site
  • Leipzig, Germany, 04107
    • Pfizer Investigational Site
  • Leverkusen, Germany, 51373
    • Pfizer Investigational Site
  • Magdeburg, Germany, 39104
    • Pfizer Investigational Site
  • Mannheim, Germany, 68165
    • Pfizer Investigational Site
  • Muenchen, Germany, 80336
    • Pfizer Investigational Site
  • Neubrandenburg, Germany, 17033
    • Pfizer Investigational Site
  • Oldenburg, Germany, 26121
    • Pfizer Investigational Site
  • Osnabrueck, Germany, 49074
    • Pfizer Investigational Site
  • Pirna, Germany, 01796
    • Pfizer Investigational Site
  • Ratingen, Germany, D40882
    • Pfizer Investigational Site
  • Regensburg, Germany
    • Pfizer Investigational Site
  • Remscheid, Germany, 42897
    • Pfizer Investigational Site
  • Rheine, Germany, 48431
    • Pfizer Investigational Site
  • Rostock, Germany, 18059
    • Pfizer Investigational Site
  • Saarbruecken, Germany, 66111
    • Pfizer Investigational Site
  • Seesen, Germany, 38723
    • Pfizer Investigational Site
  • Surwold, Germany, 26903
    • Pfizer Investigational Site
  • Tuebingen, Germany, 72076
    • Pfizer Investigational Site
  • Villingen-Schwenningen, Germany, 78054
    • Pfizer Investigational Site
  • Weener, Germany, 26826
    • Pfizer Investigational Site
  • Winsen/Luhe, Germany, 21423
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Celecoxib; 200 mg oral capsule once daily for 12 weeks; Drug: Celecoxib; 200 mg oral capsule twice daily for 12 weeks
Experimental: B	Drug: Celecoxib; 200 mg oral capsule once daily for 12 weeks; Drug: Celecoxib; 200 mg oral capsule twice daily for 12 weeks
Active Comparator: C	Drug: Diclofenac; 75 mg oral capsule twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Adverse events	Week 12
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
Physical evaluation	Week 12
Laboratory tests	Week 12
Nocturnal pain	Weeks 1, 2, 6, and 12
Composite Bath Ankylosing Spondylitis Disease Activity Index	Weeks 1, 2, 6, and 12
Bath Ankylosing Spondylitis Metrology Index	Weeks 1, 2, 6, and 12
Change from baseline in C-reactive protein measurement	Week 12
Responder rates, defined as 50% improvement in VAS from baseline	Weeks 1, 2, and 6
Mobility parameters	Weeks 1, 2, 6, and 12
Change from baseline in Assessments in Ankylosing Spondylitis 20 score	Weeks 1, 2, 6, and 12
Change from baseline in global pain intensity	Weeks 1, 2, and 6
Bath Ankylosing Spondylitis Functional Index	Weeks 1, 2, 6, and 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): April 10, 2008
• Last Update Submitted That Met QC Criteria: April 7, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib; Diclofenac
• Other Study ID Numbers: COXA-0508-243; A3191098