DS-5565 in pain associated with fibromyalgia (FM)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Subjects with Pain Associated with Fibromyalgia
IRAS ID
162110
Contact name
Anthony Jones
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2013-005163-10
Research summary
The main purpose of this study is to collect information about a new drug called DS-5565 that may help participants who have pain associated with Fibromyalgia. Fibromyalgia is a disease characterised by persistent muscle pain, fatigue, and some sensitive painful parts in the body,
It is also associated with sleep problems, fatigue, depression, and anxiety.
This study is to test the safety and effectiveness of DS-5565, compared to placebo (a substance containing no medication) or Pregabalin in patients with fibromyalgia. (Pregabalin is an approved treatment for pain in this condition, fibromyalgia in the United States.) DS-5565 has not yet been approved for treatment of pain associated with Fibromyalgia and it is for investigational use only.
The study will last approximately 21 weeks. Participants will be asked to attend 12 visits in the clinic and will receive 3 phone calls from the study staff.
There will be an initial period (screening) of no more than 30 days to determine if participants can be included (eligible) in the study. After screening, if participants qualify for the study and are taking medications not allowed during the study, the study staff will call them to explain which of their current pain medication (s) they should stop and for how long. This is called washout.
If participants are eligible for the study and have completed screening and washout procedures, they will return to the clinic for the baseline visit.
Following the baseline visit there will be 13 weeks treatment during which participants will receive the study drug (DS-5565, Pregabalin or placebo) followed by 1 week tapering and 4 weeks follow up period.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1373
Date of REC Opinion
18 Dec 2014
REC opinion
Further Information Favourable Opinion