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

Primary Purpose

Spondylitis, Ankylosing

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Celecoxib

Diclofenac

About this trial

This is an interventional treatment trial for Spondylitis, Ankylosing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in global pain intensity as assessed by visual analog scale (VAS)

Responder rates, defined as 50% improvement in VAS from baseline

Secondary Outcome Measures

Patient's and physician's global assessment of disease activity

Spinal pain

Short Form-12

Adverse events

Physical evaluation

Laboratory tests

Nocturnal pain

Composite Bath Ankylosing Spondylitis Disease Activity Index

Bath Ankylosing Spondylitis Metrology Index

Change from baseline in C-reactive protein measurement

Responder rates, defined as 50% improvement in VAS from baseline

Mobility parameters

Change from baseline in Assessments in Ankylosing Spondylitis 20 score

Change from baseline in global pain intensity

Bath Ankylosing Spondylitis Functional Index

Full Information

NCT ID

NCT00648141

First Posted

March 28, 2008

Last Updated

April 7, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00648141

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondylitis, Ankylosing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

458 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

200 mg oral capsule once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

200 mg oral capsule twice daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Diclofenac

Intervention Description

75 mg oral capsule twice daily for 12 weeks

Primary Outcome Measure Information:

Title

Change from baseline in global pain intensity as assessed by visual analog scale (VAS)

Time Frame

Week 12

Title

Responder rates, defined as 50% improvement in VAS from baseline

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Patient's and physician's global assessment of disease activity

Time Frame

Weeks 1, 2, 6, and 12

Title

Spinal pain

Time Frame

Weeks 1, 2, 6, and 12

Title

Short Form-12

Time Frame

Weeks 1, 2, 6, and 12

Title

Adverse events

Time Frame

Week 12

Title

Physical evaluation

Time Frame

Week 12

Title

Laboratory tests

Time Frame

Week 12

Title

Nocturnal pain

Time Frame

Weeks 1, 2, 6, and 12

Title

Composite Bath Ankylosing Spondylitis Disease Activity Index

Time Frame

Weeks 1, 2, 6, and 12

Title

Bath Ankylosing Spondylitis Metrology Index

Time Frame

Weeks 1, 2, 6, and 12

Title

Change from baseline in C-reactive protein measurement

Time Frame

Week 12

Title

Responder rates, defined as 50% improvement in VAS from baseline

Time Frame

Weeks 1, 2, and 6

Title

Mobility parameters

Time Frame

Weeks 1, 2, 6, and 12

Title

Change from baseline in Assessments in Ankylosing Spondylitis 20 score

Time Frame

Weeks 1, 2, 6, and 12

Title

Change from baseline in global pain intensity

Time Frame

Weeks 1, 2, and 6

Title

Bath Ankylosing Spondylitis Functional Index

Time Frame

Weeks 1, 2, 6, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Aachen

ZIP/Postal Code

52064

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bad Aibling

ZIP/Postal Code

83043

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bad Iburg

ZIP/Postal Code

49186

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bad Muender

ZIP/Postal Code

31848

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10559

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10777

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12247

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

D-10098

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bonn

ZIP/Postal Code

53179

Country

Germany

Facility Name

Pfizer Investigational Site

City

Celle / OT Klein Hehlen

ZIP/Postal Code

29223

Country

Germany

Facility Name

Pfizer Investigational Site

City

Chemnitz

ZIP/Postal Code

09130

Country

Germany

Facility Name

Pfizer Investigational Site

City

Darmstadt

ZIP/Postal Code

64295

Country

Germany

Facility Name

Pfizer Investigational Site

City

Dresden

Country

Germany

Facility Name

Pfizer Investigational Site

City

Duesseldorf

ZIP/Postal Code

40211

Country

Germany

Facility Name

Pfizer Investigational Site

City

Elmshorn

ZIP/Postal Code

25335

Country

Germany

Facility Name

Pfizer Investigational Site

City

Erlangen

ZIP/Postal Code

91056

Country

Germany

Facility Name

Pfizer Investigational Site

City

Halle

ZIP/Postal Code

06128

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hannover

ZIP/Postal Code

30161

Country

Germany

Facility Name

Pfizer Investigational Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hofheim

ZIP/Postal Code

65719

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hoyerswerda

ZIP/Postal Code

02977

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

51107

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leverkusen

ZIP/Postal Code

51373

Country

Germany

Facility Name

Pfizer Investigational Site

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mannheim

ZIP/Postal Code

68165

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Pfizer Investigational Site

City

Neubrandenburg

ZIP/Postal Code

17033

Country

Germany

Facility Name

Pfizer Investigational Site

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Facility Name

Pfizer Investigational Site

City

Osnabrueck

ZIP/Postal Code

49074

Country

Germany

Facility Name

Pfizer Investigational Site

City

Pirna

ZIP/Postal Code

01796

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ratingen

ZIP/Postal Code

D40882

Country

Germany

Facility Name

Pfizer Investigational Site

City

Regensburg

Country

Germany

Facility Name

Pfizer Investigational Site

City

Remscheid

ZIP/Postal Code

42897

Country

Germany

Facility Name

Pfizer Investigational Site

City

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

Pfizer Investigational Site

City

Rostock

ZIP/Postal Code

18059

Country

Germany

Facility Name

Pfizer Investigational Site

City

Saarbruecken

ZIP/Postal Code

66111

Country

Germany

Facility Name

Pfizer Investigational Site

City

Seesen

ZIP/Postal Code

38723

Country

Germany

Facility Name

Pfizer Investigational Site

City

Surwold

ZIP/Postal Code

26903

Country

Germany

Facility Name

Pfizer Investigational Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Pfizer Investigational Site

City

Villingen-Schwenningen

ZIP/Postal Code

78054

Country

Germany

Facility Name

Pfizer Investigational Site

City

Weener

ZIP/Postal Code

26826

Country

Germany

Facility Name

Pfizer Investigational Site

City

Winsen/Luhe

ZIP/Postal Code

21423

Country

Germany

12. IPD Sharing Statement

Links:

URL

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

Description

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Learn more about this trial

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

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

Spondylitis, Ankylosing

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial