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

    NCT00798967

  • 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