NCT02187159

Treatment of Pain Associated With Fibromyalgia

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,270 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 participant that best describes his or her worst pain over the previous 24 hours.

Conditions

• Pain Associated With Fibromyalgia

Interventions

Type	Name	Description
DRUG	DS-5565	DS-5565 15 mg tablet for oral administration
DRUG	Pregabalin	Pregabalin 150 mg capsule for oral administration
DRUG	Placebo tablet	Placebo tablet (matching DS5565) for oral administration
DRUG	Placebo capsule	Placebo capsule (matching pregabalin) for oral administration

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-07-07
• Completion: 2016-07-07
• First posted: 2014-07-10
• Last updated: 2020-11-09
• Results posted: 2020-11-09

Locations

176 sites across 12 countries: United States, Australia, Bulgaria, Estonia, Hungary, India, Latvia, New Zealand, Romania, Russia, Slovakia, United Kingdom

Regulatory

• FDA-regulated drug study