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NCT02496884 · ClinicalTrials.gov registry record · Phase 3
Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT02496884: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT02496884 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02496884, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state. Relationship of TEAEs to study drug is assessed by the investigator. Clinically significant changes from baseline in clinical laboratory evaluations, neurological examinations, and electrocardiograms a
Interventions
- DRUG Placebo
- DRUG DS-5565
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-06-26 |
| Est. Completion | 2017-07-06 |
| Phase | Phase 3 |
What the finished NCT02496884 record still lists
NCT02496884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02496884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02496884 about?
NCT02496884 is a clinical study titled "Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease". 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 reduc...
What is the current status of trial NCT02496884?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2015-06-26. Estimated completion is 2017-07-06.
What interventions are being tested in trial NCT02496884?
The interventions under investigation include: Placebo (DRUG), DS-5565 (DRUG).
Who is sponsoring clinical trial NCT02496884?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02496884's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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