CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,485 enrolled
Drug / intervention
DS-5565drug
Likely dose
DS-5565 15 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/NCT02234583
NCT02234583Phase 3Completed
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An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

Daiichi Sankyo·interventional·Posted Sep 9, 2014·Updated Jul 23, 2020

In Brief

A Phase 3 clinical trial evaluating DS-5565 for Pain Associated With Fibromyalgia. Completed, enrolled 2,485 participants across 276 sites in 29 countries.

Detailed Summary

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Associated With Fibromyalgia
CountriesAustralia, Austria, Bulgaria, Canada, Chile, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 9, 2014
Enrollment StartFeb 4, 2015
Primary CompletionApr 19, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.8 years ago

Interventions

DS-5565drug

DS-5565 15 mg tablet for oral administration