A STUDY OF THE EFFICACY AND SAFETY OF TEDUGLUTIDE IN SUBJECTS WITH PARENTAL N

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objective of this INDUSTRY-INITIATED clinical study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of the GLP-2 analog teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS). This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter study. Subjects will be randomized to either teduglutide or placebo. There will be a screening visit; a PN reduction and optimization period; a baseline period which demonstrates stable administration of PN for 4 weeks; a subsequent dosing period of 24 weeks; and, for subjects not going on to the extension study, a follow-up period of 4 weeks.