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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 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02496884
The ClinicalTrials.gov registry entry for NCT02496884 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02496884 reports 0 study locations.
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.
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