A Randomized, Double-Blind, Placebo-Controlled Safety Study of DS-5565
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED SAFETY STUDY OF DS-5565 FOR TREATMENT OF PAIN DUE TO FIBROMYALGIA IN SUBJECTS WITH CHRONIC KIDNEY DISEASE
IRAS ID
182026
Contact name
Adam Ellery
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2014-003972-21
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
The purpose of this study is to gather information about an investigational drug called DS-5565 that may help to treat patient's pain, despite their reduced kidney function.
This study is to test the safety and tolerability of DS-5565 compared to placebo (like a sugar pill) in people with pain caused by fibromyalgia (FM), who also have reduced kidney function DS-5565 is an investigational drug. An investigational drug is a medication that is still being studied and has not yet been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
This study will be conducted at about 100 centers around the world in approximately 60 patients, both men and women aged 18 years or older.
Approximately 60 patients will be randomised, with approximately 45 patients completing the double-blind treatment period (Assuming a 25% dropout rate). This sample size is thought to be sufficient to address the objectives of this clinical trial.
The total study duration (individual patients) will be approximately 21 weeks. The study includes a screening period (approximately 3 weeks but no longer than 35 days, including a washout period [if necessary] and a 1-week baseline period), double-blind treatment period (13 weeks), and a 4 week follow-up period. Patients will be asked to attend 14 visits, which include three phone calls from the staff.REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0221
Date of REC Opinion
7 Sep 2015
REC opinion
Unfavourable Opinion