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A Study of Cisapride in Premature Infants With Feeding Problems

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant, Premature; Infant, Newborn

Intervention: Placebo (Drug); Cisapride (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Summary

The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.

Clinical Details

Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2mg/kg q.i.d) for the Treatment of Feeding Intolerance in Premature Infants

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time from start of study medication to full enteral feeding

Secondary outcome: Number and type of adverse events

Detailed description: This is a double-blind study where the identity of the treatment assigned (Cisapride or placebo) will not be known to the patient's legal guardian or any study staff involved with the study. Patients will be randomized (assigned by chance) to receive either the drug Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding problems (referred to as feeding intolerance) in premature newborn infants who cannot tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine. Patients will be given either cisapride at a dose of 0. 2 mg/kg or placebo as a liquid suspension through a tube from the nose to the stomach (referred to as a nasogastric tube) 15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q. i.d. schedule).

Eligibility

Minimum age: 36 Weeks. Maximum age: 99 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must be hospitalized and on continuous cardiac monitoring for the duration of the

study

- Patient has demonstrated feeding intolerance as defined by the protocol

- Patient's parent or legal guardian must sign the informed consent form

Exclusion Criteria:

- Currently active significant cardiovascular disease, as determined by the

neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)

Locations and Contacts

Additional Information

Starting date: March 2003
Last updated: January 20, 2011

Page last updated: August 23, 2015

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