CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,301 enrolled
Drug / intervention
DS-5565 +3 moredrug
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/NCT02187471
NCT02187471Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia

Daiichi Sankyo·interventional·Posted Jul 11, 2014·Updated Nov 9, 2020

In Brief

A Phase 3 clinical trial evaluating DS-5565, Pregabalin, and 2 other interventions for Pain Associated With Fibromyalgia. Completed, enrolled 1,301 participants across 154 sites in 14 countries.

Detailed Summary

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Associated With Fibromyalgia
CountriesArgentina, Austria, Belarus, Belgium, Chile, Colombia, Israel, Mexico, Poland, Portugal, Slovenia, Spain, Switzerland, United States
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 11, 2014
Enrollment StartJan 16, 2015
Primary CompletionJan 6, 2017
Study CompletionJan 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.0 years ago

Interventions

DS-5565drug

DS-5565 15 mg QD or BID; tablet for oral use

Pregabalindrug

Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule

Placebo tabletdrug

Placebo tablet for oral use, matching DS-5565 tablet

Placebo capsuledrug

Placebo capsule for oral use, matching pregabalin capsule