This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000039-47
Application #
7603633
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-12-01
Project End
2007-09-16
Budget Start
2006-12-01
Budget End
2007-09-16
Support Year
47
Fiscal Year
2007
Total Cost
$2,953
Indirect Cost
Name
Emory University
Department
Dermatology
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
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