NCT02234583

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,485 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	DS-5565	DS-5565 15 mg tablet for oral administration

Timeline

• Start date: 2015-02-04
• Primary completion: 2017-04-19
• Completion: 2017-04-19
• First posted: 2014-09-09
• Last updated: 2020-07-23
• Results posted: 2020-07-23

Locations

276 sites across 29 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