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

Spondylitis, Ankylosing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648141
• Other study ID #: COXA-0508-243
• Secondary ID: A3191098
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2008
• Last updated: April 7, 2008
• Start date: January 2003
• Est. completion date: January 2005

Study information

• Verified date: March 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Celecoxib
200 mg oral capsule once daily for 12 weeks
• Celecoxib
200 mg oral capsule twice daily for 12 weeks
• Diclofenac
75 mg oral capsule twice daily for 12 weeks

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Aachen
Germany	Pfizer Investigational Site	Bad Aibling
Germany	Pfizer Investigational Site	Bad Iburg
Germany	Pfizer Investigational Site	Bad Muender
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Celle / OT Klein Hehlen
Germany	Pfizer Investigational Site	Chemnitz
Germany	Pfizer Investigational Site	Darmstadt
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Duesseldorf
Germany	Pfizer Investigational Site	Elmshorn
Germany	Pfizer Investigational Site	Erlangen
Germany	Pfizer Investigational Site	Halle
Germany	Pfizer Investigational Site	Hannover
Germany	Pfizer Investigational Site	Heidelberg
Germany	Pfizer Investigational Site	Hildesheim
Germany	Pfizer Investigational Site	Hofheim
Germany	Pfizer Investigational Site	Hoyerswerda
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Leverkusen
Germany	Pfizer Investigational Site	Magdeburg
Germany	Pfizer Investigational Site	Mannheim
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Neubrandenburg
Germany	Pfizer Investigational Site	Oldenburg
Germany	Pfizer Investigational Site	Osnabrueck
Germany	Pfizer Investigational Site	Pirna
Germany	Pfizer Investigational Site	Ratingen
Germany	Pfizer Investigational Site	Regensburg
Germany	Pfizer Investigational Site	Remscheid
Germany	Pfizer Investigational Site	Rheine
Germany	Pfizer Investigational Site	Rostock
Germany	Pfizer Investigational Site	Saarbruecken
Germany	Pfizer Investigational Site	Seesen
Germany	Pfizer Investigational Site	Surwold
Germany	Pfizer Investigational Site	Tuebingen
Germany	Pfizer Investigational Site	Villingen-Schwenningen
Germany	Pfizer Investigational Site	Weener
Germany	Pfizer Investigational Site	Winsen/Luhe

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in global pain intensity as assessed by visual analog scale (VAS)		Week 12	No
Primary	Responder rates, defined as 50% improvement in VAS from baseline		Week 12	No
Secondary	Patient's and physician's global assessment of disease activity		Weeks 1, 2, 6, and 12	No
Secondary	Spinal pain		Weeks 1, 2, 6, and 12	No
Secondary	Short Form-12		Weeks 1, 2, 6, and 12	No
Secondary	Adverse events		Week 12	Yes
Secondary	Physical evaluation		Week 12	Yes
Secondary	Laboratory tests		Week 12	Yes
Secondary	Nocturnal pain		Weeks 1, 2, 6, and 12	No
Secondary	Composite Bath Ankylosing Spondylitis Disease Activity Index		Weeks 1, 2, 6, and 12	No
Secondary	Bath Ankylosing Spondylitis Metrology Index		Weeks 1, 2, 6, and 12	No
Secondary	Change from baseline in C-reactive protein measurement		Week 12	No
Secondary	Responder rates, defined as 50% improvement in VAS from baseline		Weeks 1, 2, and 6	No
Secondary	Mobility parameters		Weeks 1, 2, 6, and 12	No
Secondary	Change from baseline in Assessments in Ankylosing Spondylitis 20 score		Weeks 1, 2, 6, and 12	No
Secondary	Change from baseline in global pain intensity		Weeks 1, 2, and 6	No
Secondary	Bath Ankylosing Spondylitis Functional Index		Weeks 1, 2, 6, and 12	No

External Links

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