CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,293 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/NCT02146430
NCT02146430Phase 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 May 23, 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 1,293 participants across 165 sites in 11 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 subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant 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
CountriesCanada, Czechia, Denmark, Finland, France, Germany, Netherlands, Norway, Serbia, Sweden, United States
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 23, 2014
Enrollment StartOct 27, 2014
Primary CompletionJul 14, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.1 years ago

Interventions

DS-5565drug

DS-5565 15 mg tablet for oral administration

Pregabalindrug

Pregabalin 150 mg capsule for oral administration

Placebo tabletdrug

Placebo tablet (matching DS-5565) for oral administration

Placebo capsuledrug

Placebo capsule (matching pregabalin) for oral administration