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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00648141

Enrollment

458

Registered

2008-04-01

Start date

2003-01-31

Completion date

2005-01-31

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylitis, Ankylosing

Brief summary

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

Interventions

DRUGCelecoxib

200 mg oral capsule once daily for 12 weeks

DRUGDiclofenac

75 mg oral capsule twice daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in global pain intensity as assessed by visual analog scale (VAS)	Week 12
Responder rates, defined as 50% improvement in VAS from baseline	Week 12

Secondary

Measure	Time frame
Short Form-12	Weeks 1, 2, 6, and 12
Adverse events	Week 12
Physical evaluation	Week 12
Laboratory tests	Week 12
Nocturnal pain	Weeks 1, 2, 6, and 12
Composite Bath Ankylosing Spondylitis Disease Activity Index	Weeks 1, 2, 6, and 12
Patient's and physician's global assessment of disease activity	Weeks 1, 2, 6, and 12
Change from baseline in C-reactive protein measurement	Week 12
Responder rates, defined as 50% improvement in VAS from baseline	Weeks 1, 2, and 6
Mobility parameters	Weeks 1, 2, 6, and 12
Change from baseline in Assessments in Ankylosing Spondylitis 20 score	Weeks 1, 2, 6, and 12
Change from baseline in global pain intensity	Weeks 1, 2, and 6
Bath Ankylosing Spondylitis Functional Index	Weeks 1, 2, 6, and 12
Bath Ankylosing Spondylitis Metrology Index	Weeks 1, 2, 6, and 12
Spinal pain	Weeks 1, 2, 6, and 12

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026