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An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

NCT02234583 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2485

Last updated 2020-07-23

Study results available
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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.

Conditions

  • Pain Associated With Fibromyalgia

Interventions

DRUG

DS-5565

DS-5565 15 mg tablet for oral administration

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-04
Primary Completion
2017-04-19
Completion
2017-04-19

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234583 on ClinicalTrials.gov