Teduglutide in PN-Dependent Short Bowel Syndrome (NPS 020)
Research type
Research Study
Full title
TEDUGLUTIDE (ALX-0600) A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome
IRAS ID
12863
Sponsor organisation
NPS Pharmaceuticals Inc
Eudract number
2008-006193-15
Clinicaltrials.gov Identifier
Research summary
This study is 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). This means they receive their nutrition through a vein. 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. About 86 patients will take part in this study.Patients will be placed into one of two treatment groups where they will receive either teduglutide or placebo (dummy drug). Half will take teduglutide and half will have placebo. Patients have an equal chance of receiving teduglutide or placebo. The drug will be given as a self-administered injection everyday for 24 weeks. Patients will be expected to attend at least 7 visits during this time and to keep a diary about their PN.
REC name
London - Harrow Research Ethics Committee
REC reference
09/H0709/3
Date of REC Opinion
16 Feb 2009
REC opinion
Further Information Favourable Opinion