Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis

2014-08-27 03:58:14 | BioPortfolio


OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo.

II. Compare morbidity and mortality rates in this patient population. III. Evaluate ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the administration of sincalide or placebo to assess the development of biliary sludge and biliary stone formation.


PROTOCOL OUTLINE: This is a randomized, placebo controlled, double blind, multicenter study. Patients are stratified according to prematurity or surgical group.

Patients are randomized to receive either placebo or sincalide IV over 10 to 15 minutes every 12 hours until a total of 8 weeks of therapy is administered or greater than 50% of their nutrition is enteral.

Patients are followed for a maximum of 2 years.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment






Johns Hopkins Oncology Center
United States




FDA Office of Orphan Products Development

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:58:14-0400

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