A Study of Cisapride in Premature Infants With Feeding Problems

January 20, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
Cisapride 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days
Drug: Cisapride
0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days
Placebo Comparator: 002
Placebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
Drug: Placebo
liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from start of study medication to full enteral feeding
Time Frame: Up to 42 days
Up to 42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and type of adverse events
Time Frame: Up to 42 days
Up to 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003955
  • CIS-INT-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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