NCT02187159.

Trial name or title	A randomized, double‐blind, placebo‐ and active‐controlled study of DS‐5565 for treatment of pain associated with fibromyalgia
Methods	13‐week randomised, parallel, double‐blind, placebo‐ and active‐controlled study
Participants	Estimated 1270 Fibromylagia (ACR), pain intensity ≥ 40/100 Men and women over 18 years
Interventions	DS‐5565 15 mg tablet 150 mg pregabalin capsule Placebo tablet matching DS‐5565 tablet Placebo capsule matching pregabalin capsule 75 mg pregabalin capsule
Outcomes	Change in weekly average daily pain score, DS‐5565 versus placebo
Starting date	October 2014
Contact information	Daiichi Sankyo Inc, Domenico Merante, MD
Notes	Estimated completion date: March 2017

ACR: American College of Rheumatology; PGIC: Patient Global Impression of Change