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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: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT02234583 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 2,485 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (222% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.
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 |
What the finished NCT02234583 record still lists
NCT02234583 is an interventional study that assigns participants to a tested intervention. Its 2,485 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (222% higher).
The record links to 0 conditions, and to 1 intervention - of which DS-5565 is the first listed.
NCT02234583 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02234583's enrollment target sits among peer trials
2,485 88th of 2000 higher than 1,913 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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