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

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

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.

Sponsors & Collaborators

• Organon and Co

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-27

Primary Completion

2014-11-12

Completion

2014-11-12