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

• ClinicalTrials.gov Identifier: NCT00004414
• Recruitment Status: Completed
• First Posted: October 19, 1999
• Last Update Posted: March 25, 2015
• Sponsor: University of Michigan
• Information provided by: FDA Office of Orphan Products Development

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cholestasis	Drug: sincalide	Not Applicable

Detailed Description:

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.

Completion date provided represents the completion date of the grant per OOPD records

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 252 participants
• Allocation: Randomized
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: September 1997
• Study Completion Date: June 2002

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: up to 30 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Oncology Center

Baltimore, Maryland, United States, 21231

United States, Michigan

University of Michigan Medical School

Ann Arbor, Michigan, United States, 48109-0718

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, Ohio

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, United States, 45229-3039

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, Texas

Baylor University Medical Center

Dallas, Texas, United States, 75246

Sponsors and Collaborators

University of Michigan

Investigators

• Study Chair: Daniel Hillel Teitelbaum; University of Michigan

More Information

• ClinicalTrials.gov Identifier: NCT00004414
• Other Study ID Numbers: 199/13306; UMMS-FDR001449
• First Posted: October 19, 1999
• Last Update Posted: March 25, 2015
• Last Verified: May 1999

Keywords provided by FDA Office of Orphan Products Development:

cholestasis; gastrointestinal disorders; rare disease

Additional relevant MeSH terms:

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases