Skip to main content
OpenTrials
Completed

NCT Number: NCT00648141

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

200 mg oral capsule once daily for 12 weeks

Diclofenac

Drug

75 mg oral capsule twice daily for 12 weeks

Primary outcomes

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

    Time frame: Week 12

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Weeks 1, 2, 6, and 12

  2. Spinal pain

    Time frame: Weeks 1, 2, 6, and 12

  3. Short Form-12

    Time frame: Weeks 1, 2, 6, and 12

  4. Adverse events

    Time frame: Week 12

  5. Physical evaluation

    Time frame: Week 12

  6. Laboratory tests

    Time frame: Week 12

  7. Nocturnal pain

    Time frame: Weeks 1, 2, 6, and 12

  8. Composite Bath Ankylosing Spondylitis Disease Activity Index

    Time frame: Weeks 1, 2, 6, and 12

  9. Bath Ankylosing Spondylitis Metrology Index

    Time frame: Weeks 1, 2, 6, and 12

  10. Change from baseline in C-reactive protein measurement

    Time frame: Week 12

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

    Time frame: Weeks 1, 2, and 6

  12. Mobility parameters

    Time frame: Weeks 1, 2, 6, and 12

  13. Change from baseline in Assessments in Ankylosing Spondylitis 20 score

    Time frame: Weeks 1, 2, 6, and 12

  14. Change from baseline in global pain intensity

    Time frame: Weeks 1, 2, and 6

  15. Bath Ankylosing Spondylitis Functional Index

    Time frame: Weeks 1, 2, 6, and 12

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Apr 1, 2008
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.