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NCT02146430 · ClinicalTrials.gov registry record · Phase 3
Treatment of Pain Associated With Fibromyalgia
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,293
- Enrollment target
NCT02146430: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT02146430 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 1,293 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02146430, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,293 participants
- Enrollment target
Study Summary
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.
Primary Outcome
Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported.
Interventions
- DRUG Placebo tablet
- DRUG Pregabalin
- DRUG Placebo capsule
- DRUG DS-5565
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,293 participants |
| Start Date | 2014-10-27 |
| Est. Completion | 2016-07-14 |
| Phase | Phase 3 |
What the finished NCT02146430 record still lists
NCT02146430 is an interventional study that assigns participants to a tested intervention. Its 1,293 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 (67% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo tablet is the first listed.
NCT02146430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02146430 about?
NCT02146430 is a clinical study titled "Treatment of Pain Associated With Fibromyalgia". The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over t...
What is the current status of trial NCT02146430?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,293 participants. The study started on 2014-10-27. Estimated completion is 2016-07-14.
What interventions are being tested in trial NCT02146430?
The interventions under investigation include: Placebo tablet (DRUG), Pregabalin (DRUG), Placebo capsule (DRUG), DS-5565 (DRUG).
Who is sponsoring clinical trial NCT02146430?
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 NCT02146430's enrollment target sits among peer trials
1,293 196th of 2000 higher than 1,805 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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