NCT01208207

A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)

A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,015 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
DRUG	Part I - etoricoxib 60 mg	etoricoxib 60 mg oral tablet once daily for 6 weeks
DRUG	Part I - etoricoxib 90 mg	etoricoxib 90 mg oral tablet once daily for 6 weeks
DRUG	Part I- naproxen 1000 mg	naproxen 500 mg oral tablet twice daily for 6 weeks
DRUG	Part I - Placebo to naproxen 500 mg	Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
DRUG	Part II- etoricoxib 60 mg	etoricoxib 60 mg oral tablet once daily for 20 weeks
DRUG	Part II- etoricoxib 90 mg	etoricoxib 90 mg oral tablet once daily for 20 weeks
DRUG	Part II- naproxen 1000 mg	naproxen 500 mg oral tablet twice daily for 20 weeks
DRUG	Part I - Placebo to etoricoxib 60 mg	Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.
DRUG	Part I - Placebo to etoricoxib 90 mg	Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.
DRUG	Part II- Placebo to etoricoxib 60 mg	Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.
DRUG	Part II - Placebo to etoricoxib 90 mg	Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.
DRUG	Part II- Placebo to naproxen 500 mg	Placebo to naproxen 500 mg orally twice daily for 20 weeks.

Timeline

• Start date: 2010-09-27
• Primary completion: 2014-11-12
• Completion: 2014-11-12
• First posted: 2010-09-23
• Last updated: 2024-06-18
• Results posted: 2015-07-02