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

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004414
First received: October 18, 1999
Last updated: September 6, 2006
Last verified: May 1999

October 18, 1999
September 6, 2006
September 1997
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Complete list of historical versions of study NCT00004414 on ClinicalTrials.gov Archive Site
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Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
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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.

Interventional
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Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Cholestasis
Drug: sincalide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
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PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Severely premature neonates (less than 1000 g at birth and estimated gestational age of no greater than 28 weeks) that require greater than 50% of caloric requirements by parenteral means within 7 days of birth OR Neonates with one or more of the following surgical conditions: Necrotizing enterocolitis Gastroschisis Severe jejunal-ileal atresia within 7 days of diagnosis --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics No other cardiovascular (thoracotomy) or major gastrointestinal surgery (laparotomy) during the newborn period Other: No prior or concurrent ursodeoxycholic acid No concurrent use of extracorporeal life support --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Conjugated bilirubin no greater than 1.0 mg/dL No primary or secondary liver disease No hepatic insufficiency as documented by either a biopsy with cirrhosis or elevated prothrombin time without evidence of systemic coagulopathy and no administration of an anticoagulant Renal: No renal failure as indicated by a progressive increase in creatinine levels Other: No hemodynamic instability No documented communicable infection (including infectious hepatitis or HIV) No metabolic pathway defect that is associated with liver dysfunction in the neonatal period including hereditary fructose intolerance, galactosemia due to transferase deficiency, and neonatal tyrosinemia

Both
up to 30 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004414
199/13306, UMMS-FDR001449
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FDA Office of Orphan Products Development
University of Michigan
Study Chair: Daniel Hillel Teitelbaum University of Michigan
FDA Office of Orphan Products Development
May 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP