Conditions: Spondylitis, Ankylosing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1015
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the efficacy and tolerability of two doses of etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with etoricoxib 60 mg. Additionally the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that the improvement in Spinal Pain Intensity visual analog scale (VAS) as measured by the time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.

Detailed description:

Arms:
arm 1: The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II arm 2: The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II arm 3: The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II arm 4: The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II

Interventions: intervention 1: Part I - etoricoxib 60 mg intervention 2: Part I - etoricoxib 90 mg intervention 3: Part I- naproxen 1000 mg intervention 4: Part I - Placebo to naproxen 500 mg intervention 5: Part II- etoricoxib 60 mg intervention 6: Part II- etoricoxib 90 mg intervention 7: Part II- naproxen 1000 mg intervention 8: Part I - Placebo to etoricoxib 60 mg intervention 9: Part I - Placebo to etoricoxib 90 mg intervention 10: Part II- Placebo to etoricoxib 60 mg intervention 11: Part II - Placebo to etoricoxib 90 mg intervention 12: Part II- Placebo to naproxen 500 mg
Intervention descriptions: intervention 1: etoricoxib 60 mg oral tablet once daily for 6 weeks intervention 2: etoricoxib 90 mg oral tablet once daily for 6 weeks intervention 3: naproxen 500 mg oral tablet twice daily for 6 weeks intervention 4: Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks intervention 5: etoricoxib 60 mg oral tablet once daily for 20 weeks intervention 6: etoricoxib 90 mg oral tablet once daily for 20 weeks intervention 7: naproxen 500 mg oral tablet twice daily for 20 weeks intervention 8: Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks. intervention 9: Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks. intervention 10: Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks. intervention 11: Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks. intervention 12: Placebo to naproxen 500 mg orally twice daily for 20 weeks.

Protocol document: