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NCT02234583 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,485
- Enrollment target
NCT02234583 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 2,485 participants.
The verdict
NCT02234583, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,485 participants
- Enrollment target
Study Summary
This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.
Interventions
- DRUG DS-5565
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,485 participants |
| Start Date | 2015-02-04 |
| Est. Completion | 2017-04-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02234583
The ClinicalTrials.gov registry entry for NCT02234583 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,485 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 1 intervention - of which DS-5565 is the first listed.
NCT02234583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02234583 about?
NCT02234583 is a clinical study titled "An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia". This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigne...
What is the current status of trial NCT02234583?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,485 participants. The study started on 2015-02-04. Estimated completion is 2017-04-19.
What interventions are being tested in trial NCT02234583?
The interventions under investigation include: DS-5565 (DRUG).
Who is sponsoring clinical trial NCT02234583?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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