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NCT02187471 · 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
1,301
Enrollment target

NCT02187471: Completed Phase 3 study, sponsored by Daiichi Sankyo.

NCT02187471 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 1,301 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02187471, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 3
Development phase
1,301 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 participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject 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

FieldValue
Enrollment Target 1,301 participants
Start Date 2015-01-16
Est. Completion 2017-01-12
Phase Phase 3
Daiichi Sankyo

236 total trials

What the finished NCT02187471 record still lists

NCT02187471 is an interventional study that assigns participants to a tested intervention. Its 1,301 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 (69% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo tablet is the first listed.

NCT02187471 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02187471 about?

NCT02187471 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 participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over ...

What is the current status of trial NCT02187471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,301 participants. The study started on 2015-01-16. Estimated completion is 2017-01-12.

What interventions are being tested in trial NCT02187471?

The interventions under investigation include: Placebo tablet (DRUG), Pregabalin (DRUG), Placebo capsule (DRUG), DS-5565 (DRUG).

Who is sponsoring clinical trial NCT02187471?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02187471's enrollment target sits among peer trials

1,301 188th of 2000 higher than 1,812 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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Source: ClinicalTrials.gov NCT02187471, the US trial registry maintained by the National Library of Medicine. NCT02187471 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.