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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00648141
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Spondylitis, Ankylosing
Drug: Celecoxib
Drug: Diclofenac
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in global pain intensity as assessed by visual analog scale (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Responder rates, defined as 50% improvement in VAS from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's and physician's global assessment of disease activity [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Spinal pain [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Short Form-12 [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Physical evaluation [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Nocturnal pain [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Composite Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Metrology Index [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in C-reactive protein measurement [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Responder rates, defined as 50% improvement in VAS from baseline [ Time Frame: Weeks 1, 2, and 6 ] [ Designated as safety issue: No ]
  • Mobility parameters [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in Assessments in Ankylosing Spondylitis 20 score [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in global pain intensity [ Time Frame: Weeks 1, 2, and 6 ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Functional Index [ Time Frame: Weeks 1, 2, 6, and 12 ] [ Designated as safety issue: No ]

Enrollment: 458
Study Start Date: January 2003
Study Completion Date: January 2005
Arms Assigned Interventions
Experimental: A Drug: Celecoxib
200 mg oral capsule once daily for 12 weeks
Experimental: B 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648141

Locations
Germany
Pfizer Investigational Site
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, 13125
Pfizer Investigational Site
Berlin, Germany, D-10098
Pfizer Investigational Site
Berlin, Germany, 14059
Pfizer Investigational Site
Berlin, Germany, 12200
Pfizer Investigational Site
Berlin, Germany, 10559
Pfizer Investigational Site
Berlin, Germany, 12247
Pfizer Investigational Site
Berlin, Germany, 10777
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00648141     History of Changes
Other Study ID Numbers: COXA-0508-243, A3191098
Study First Received: March 28, 2008
Last Updated: April 7, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Celecoxib
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014