NCT02187471

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: 1,301 (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 subject 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 QD or BID; tablet for oral use
DRUG	Pregabalin	Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule
DRUG	Placebo tablet	Placebo tablet for oral use, matching DS-5565 tablet
DRUG	Placebo capsule	Placebo capsule for oral use, matching pregabalin capsule

Timeline

• Start date: 2015-01-16
• Primary completion: 2017-01-06
• Completion: 2017-01-12
• First posted: 2014-07-11
• Last updated: 2020-11-09
• Results posted: 2020-11-09

Locations

154 sites across 14 countries: United States, Argentina, Austria, Belarus, Belgium, Chile, Colombia, Israel, Mexico, Poland, Portugal, Slovenia, Spain, Switzerland