Abstract

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.

  Funding Agency

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

  Institution

Name
Emory University
Department
Dermatology
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322

  Publications

Yu, Alan S L; Shen, Chengli; Landsittel, Douglas P et al. (2018) Baseline total kidney volume and the rate of kidney growth are associated with chronic kidney disease progression in Autosomal Dominant Polycystic Kidney Disease. Kidney Int 93:691-699
Stevens, Jennifer S; Reddy, Renuka; Kim, Ye Ji et al. (2018) Episodic memory after trauma exposure: Medial temporal lobe function is positively related to re-experiencing and inversely related to negative affect symptoms. Neuroimage Clin 17:650-658
Huang, Yunfeng; Hui, Qin; Walker, Douglas I et al. (2018) Untargeted metabolomics reveals multiple metabolites influencing smoking-related DNA methylation. Epigenomics 10:379-393
Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Lin, Cliff; Michopoulos, Vasiliki; Powers, Abigail et al. (2018) Affect, inflammation, and health in urban at-risk civilians. J Psychiatr Res 104:24-31
Hardy, Raven; Fani, Negar; Jovanovic, Tanja et al. (2018) Food addiction and substance addiction in women: Common clinical characteristics. Appetite 120:367-373
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Logue, Mark W; van Rooij, Sanne J H; Dennis, Emily L et al. (2018) Smaller Hippocampal Volume in Posttraumatic Stress Disorder: A Multisite ENIGMA-PGC Study: Subcortical Volumetry Results From Posttraumatic Stress Disorder Consortia. Biol Psychiatry 83:244-253
McKenzie, Katelyn A; El Ters, Mirelle; Torres, Vicente E et al. (2018) Relationship between caffeine intake and autosomal dominant polycystic kidney disease progression: a retrospective analysis using the CRISP cohort. BMC Nephrol 19:378
Dad, Taimur; Abebe, Kaleab Z; Bae, K Ty et al. (2018) Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease. Kidney Int Rep 3:619-624

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