A Study of Cisapride in Premature Infants With Feeding Problems

This study has been terminated.
(Sponsor request)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01281566
First received: January 20, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Infant, Premature
Infant, Newborn
Drug: Placebo
Drug: Cisapride
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Time from start of study medication to full enteral feeding [ Time Frame: Up to 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and type of adverse events [ Time Frame: Up to 42 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2003
Study Completion Date: July 2003
Arms Assigned Interventions
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

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

Ages Eligible for Study:   36 Weeks to 99 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281566

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Protfolio/CDT Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01281566     History of Changes
Other Study ID Numbers: CR003955, CIS-INT-28
Study First Received: January 20, 2011
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Cisapride (Prepulsid)
Feeding intolerance
Enteral feeding
Nasogastric tube
Neonate

Additional relevant MeSH terms:
Cisapride
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014