TDE-DU-202 (DISTOL-EXT)

• Research type

  Research Study

• Full title

  DISTOL-EXT: Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: An Open-Label multicenter extension study.

• IRAS ID

  13199

• Contact name

  United Therapeutics?? medical monitoring group

• Sponsor organisation

  United Therapeutics Corporation

• Eudract number

  2008-006978-15

• ISRCTN Number

  Not applicable

• Research summary

  The DISTOL-EXT clinical trial is an investigation of treprostinil diethanolamine (UT-15C SR) for the treatment and prevention 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 and prevention 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 450 participants at approximately 60 hospitals will be included in this study from Europe,USA and Canada. Participation in this study is voluntary and will last approximately 36 months from the start until the end of the study. This study is an open label extension of previous clinical trials which assures ongoing access to treprostinil diethanolamine (UT-15C SR) for eligible participants.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/2

• Date of REC Opinion

  5 Mar 2009

• REC opinion

  Further Information Favourable Opinion