CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
DS-5565 +1 moredrug
Likely dose
DS-5565 7.5 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/NCT02496884
NCT02496884Phase 3Completed
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A Randomized, Double-blind, Placebo-controlled Safety Study of DS-5565 for Treatment of Pain Due to Fibromyalgia in Subjects With Chronic Kidney Disease

Daiichi Sankyo·interventional·Posted Jul 14, 2015·Updated Nov 24, 2020

In Brief

A Phase 3 clinical trial evaluating DS-5565 and Placebo for Fibromyalgia. Completed, enrolled 56 participants across 39 sites in 8 countries.

Detailed Summary

DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia (FM) pain. Because it is excreted through the kidneys, people who have reduced kidney function will not process the drug as well as with those with normal kidney function, so the dose must be reduced. This study will test two reduced dose levels for both moderately reduced and severely reduced kidney function. The study will test the hypothesis that the drug will be safe and well-tolerated in people who have both fibromyalgia and chronic kidney disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesBulgaria, Czechia, Hungary, Poland, Romania, South Africa, Spain, United States
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 14, 2015
Enrollment StartJun 26, 2015
Primary CompletionJul 6, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.0 years ago

Interventions

DS-5565drug

DS-5565 7.5 mg tablet for oral use

Placebodrug

Placebo tablet for oral use to match DS-5565 7.5 mg tablet