CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,015 enrolled
Drug / intervention
Part I - etoricoxib 60 mg +11 moredrug
Likely dose
Part I - etoricoxib 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01208207
NCT01208207Phase 3Completed
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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

Organon and Co·interventional·Posted Sep 23, 2010·Updated Jun 18, 2024

In Brief

A Phase 3 clinical trial evaluating Part I - etoricoxib 60 mg, Part I - etoricoxib 90 mg, and 10 other interventions for Spondylitis, Ankylosing. Completed, enrolled 1,015 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpondylitis, Ankylosing
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2010
Enrollment StartSep 27, 2010
Primary CompletionNov 12, 2014
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.8 years ago

Interventions

Part I - etoricoxib 60 mgdrug

etoricoxib 60 mg oral tablet once daily for 6 weeks

Part I - etoricoxib 90 mgdrug

etoricoxib 90 mg oral tablet once daily for 6 weeks

Part I- naproxen 1000 mgdrug

naproxen 500 mg oral tablet twice daily for 6 weeks

Part I - Placebo to naproxen 500 mgdrug

Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks

Part II- etoricoxib 60 mgdrug

etoricoxib 60 mg oral tablet once daily for 20 weeks

Part II- etoricoxib 90 mgdrug

etoricoxib 90 mg oral tablet once daily for 20 weeks

Part II- naproxen 1000 mgdrug

naproxen 500 mg oral tablet twice daily for 20 weeks

Part I - Placebo to etoricoxib 60 mgdrug

Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.

Part I - Placebo to etoricoxib 90 mgdrug

Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.

Part II- Placebo to etoricoxib 60 mgdrug

Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.

Part II - Placebo to etoricoxib 90 mgdrug

Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.

Part II- Placebo to naproxen 500 mgdrug

Placebo to naproxen 500 mg orally twice daily for 20 weeks.