Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Spondylitis, Ankylosing

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2005

Estimated Enrollment :

458 Patients enrolled

Trial Details

Trial ID

NCT00648141

Start Date

January 1 2003

End Date

January 1 2005

Last Update

April 10 2008

Active Locations (47)

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Page 1 of 12 (47 locations)

1

Pfizer Investigational Site

Aachen, Germany, 52064

2

Pfizer Investigational Site

Bad Aibling, Germany, 83043

3

Pfizer Investigational Site

Bad Iburg, Germany, 49186

4

Pfizer Investigational Site

Bad Münder am Deister, Germany, 31848

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