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

NCT ID: NCT00648141

Last Updated: 2008-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

458 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-01-31

Brief Summary

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

Detailed Description

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Conditions

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Spondylitis, Ankylosing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

200 mg oral capsule once daily for 12 weeks

B

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

200 mg oral capsule twice daily for 12 weeks

C

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

75 mg oral capsule twice daily for 12 weeks

Interventions

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Celecoxib

200 mg oral capsule once daily for 12 weeks

Intervention Type DRUG

Celecoxib

200 mg oral capsule twice daily for 12 weeks

Intervention Type DRUG

Diclofenac

75 mg oral capsule twice daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Aachen, , Germany

Site Status

Pfizer Investigational Site

Bad Aibling, , Germany

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Pfizer Investigational Site

Bad Iburg, , Germany

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Pfizer Investigational Site

Bad Münder am Deister, , Germany

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Pfizer Investigational Site

Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Celle / OT Klein Hehlen, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Elmshorn, , Germany

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Erlangen, , Germany

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Halle, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Hildesheim, , Germany

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Hofheim, , Germany

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Hoyerswerda, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Magdeburg, , Germany

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Mannheim, , Germany

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München, , Germany

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Neubrandenburg, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Pirna, , Germany

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Ratingen, , Germany

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Regensburg, , Germany

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Remscheid, , Germany

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Rheine, , Germany

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Rostock, , Germany

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Saarbrücken, , Germany

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Pfizer Investigational Site

Seesen, , Germany

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Pfizer Investigational Site

Surwold, , Germany

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Pfizer Investigational Site

Tübingen, , Germany

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Pfizer Investigational Site

Villingen-Schwenningen, , Germany

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Pfizer Investigational Site

Weener, , Germany

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Pfizer Investigational Site

Winsen, , Germany

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Countries

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Germany

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=COXA-0508-243&StudyName=Safety%20and%20Efficacy%20of%20Celecoxib%20Versus%20Diclofenac%20in%20the%20Treatment%20of%20Ankylosing%20Spondylitis

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

Other Identifiers

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A3191098

Identifier Type: -

Identifier Source: secondary_id

COXA-0508-243

Identifier Type: -

Identifier Source: org_study_id