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

ClinicalTrials.gov ID: NCT02496884

Public ClinicalTrials.gov record NCT02496884. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled Safety Study of DS-5565 for Treatment of Pain Due to Fibromyalgia in Subjects With Chronic Kidney Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT02496884
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Daiichi Sankyo; Industry
Enrollment: 56 participants

Conditions and interventions

Conditions

Fibromyalgia

Interventions

DS-5565 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 26, 2015 (Actual)
Primary completion: Jul 6, 2017 (Actual)
Completion: Jul 6, 2017 (Actual)
Last update posted: Nov 24, 2020

2015 – 2017

United States locations

U.S. sites: 22
U.S. states: 14
U.S. cities: 22

Facility	City	State	ZIP	Site status
Not listed	Phoenix	Arizona	85018	—
Not listed	Colton	California	92324	—
Not listed	Los Angeles	California	90033	—
Not listed	Santa Ana	California	92705	—
Not listed	Colorado Springs	Colorado	80918	—
Not listed	Brooksville	Florida	34601	—
Not listed	DeBary	Florida	32713	—
Not listed	Hialeah	Florida	33013	—
Not listed	Kissimmee	Florida	34744	—
Not listed	Miami	Florida	33144	—
Not listed	Grand Blanc	Michigan	48439	—
Not listed	High Point	North Carolina	27262	—
Not listed	Cincinnati	Ohio	45224	—
Not listed	Wyomissing	Pennsylvania	19610	—
Not listed	Greer	South Carolina	29651	—
Not listed	Rapid City	South Dakota	57702	—
Not listed	Knoxville	Tennessee	37919	—
Not listed	Houston	Texas	77098	—
Not listed	Plano	Texas	75093	—
Not listed	Bellevue	Washington	98007	—
Not listed	Charleston	West Virginia	25304	—
Not listed	Morgantown	West Virginia	26505	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02496884, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 24, 2020 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02496884 live on ClinicalTrials.gov.

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