NPS 021
Research type
Research Study
Full title
A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel Syndrome
IRAS ID
39854
Contact name
Simon Gabe
Sponsor organisation
NPS Pharmaceuticals Inc
Eudract number
2009-011679-65
Clinicaltrials.gov Identifier
Research summary
This is a continuation study is for patients who were previously involved in the CL0600-020 study for adults with short bowel syndrome (SBS; a life-long condition caused by removal of a large part of the intestine) who need parenteral nutrition (PN). PN, however, can lead to serious side effects and currently, in the UK, there are no medicines available to reduce the amount of PN taken by patients who have SBS. Teduglutide is an experimental medicine being tested as a possible treatment for people with SBS who need PN. It is hoped that it will help to reduce the amount of PN a patient needs to have. All Patients involved in this study will be given teduglutide (the study drug) and are expected to be in this study for up to 2 years or sooner if teduglutide is approved for use in these patients and becomes available on the market. Patients will be expected to attend 12 visits during this time and to keep a diary about their PN.
REC name
London - Harrow Research Ethics Committee
REC reference
10/H0709/36
Date of REC Opinion
9 Jul 2010
REC opinion
Further Information Favourable Opinion