TDE-DU-201 (DISTOL-1)
Research type
Research Study
Full title
DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo-controlled, multicenter study.
IRAS ID
10856
Contact name
United Therapeutics?? medical monitoring group
Sponsor organisation
United Therapeutics Corporation
Eudract number
2008-005018-39
ISRCTN Number
Not applicable
Clinicaltrials.gov Identifier
Research summary
The DISTOL-I clinical trial is an investigation of treprostinil diethanolamine (UT-15C SR) for the treatment of digital ulcers (ulcers on your finger tips) caused by a condition called systemic sclerosis. Systemic sclerosis, also called scleroderma, is an autoimmune disease of the connective tissue which is often characterised by hardening, or sclerosis of the skin and other organs. Autoimmune diseases occur when the body's immune system attacks its own tissues. Systemic sclerosis is a widespread connective tissue disease that involves changes in the skin, blood vessels, muscles, and internal organs. Treprostinil diethanolamine (UT-15C SR) is an investigational drug to be used for the treatment of digital ulcers caused by systemic sclerosis or scleroderma. An investigational drug is one that has not been approved by regulatory agencies as a prescription or over-the-counter drug. This investigational drug is a tablet that is taken by mouth and its treatment effect is released over an extended period of time (sustained release, or SR). Approximately 150 participants at approximately 30 hospitals will be included in this study from the UK, USA and Canada. Participation in this study is voluntary and will last approximately 24 weeks (168 days) from the start until the end of the study. The study is placebo controlled, meaning that one group of participants (approximately 50%) will receive treprostinil diethanolamine (UT-15C SR), whilst the other group (approximately 50%) will receive tablets that appear the same but do not contain any active drug.
REC name
London - Hampstead Research Ethics Committee
REC reference
09/H0720/1
Date of REC Opinion
5 Mar 2009
REC opinion
Further Information Favourable Opinion