Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00648141
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: March 2008
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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:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
U.S. FDA Resources
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
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, D-10098 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10777 | |
| 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, 13125 | |
| 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 Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis Diclofenac Celecoxib Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013