Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease
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.
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
- Enrollment
- 56 participants
Conditions and interventions
Conditions
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 25, 2015
- Primary completion
- Jul 5, 2017
- Completion
- Jul 5, 2017
- Last update posted
- Nov 23, 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 23, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02496884 live on ClinicalTrials.gov.