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

Pfizer458 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

458

Conditions

Spondylitis, Ankylosing

Interventions

CelecoxibDRUG

200 mg oral capsule once daily for 12 weeks

CelecoxibDRUG

200 mg oral capsule twice daily for 12 weeks

DiclofenacDRUG

75 mg oral capsule twice daily for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (47)

Outcomes

Primary Outcomes

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

Time frame: Week 12

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

Time frame: Week 12

Secondary Outcomes

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

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

Spinal pain

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

Short Form-12

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

Adverse events

Time frame: Week 12

Physical evaluation

Time frame: Week 12

Laboratory tests

Time frame: Week 12

Nocturnal pain

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

Composite Bath Ankylosing Spondylitis Disease Activity Index

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

Bath Ankylosing Spondylitis Metrology Index

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

Change from baseline in C-reactive protein measurement

Time frame: Week 12

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Aachen, Germany

Pfizer Investigational Site

Bad Aibling, Germany

Pfizer Investigational Site

Bad Iburg, Germany

Pfizer Investigational Site

Bad Münder am Deister, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

...and 37 more locations