drugset / Trial / NCT02496884

Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease

NCT02496884

Phase 3 Completed 56 enrolled Daiichi Sankyo Syneos Health · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-06-26
Primary completion
2017-07-06
Completion
2017-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirogabalin Small molecule 7.5 mg Oral

Indications