Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532518
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Menarini Group

Brief Summary:
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.

Condition or disease Intervention/treatment Phase
Colic Drug: Nepadutant Phase 2

Detailed Description:

Feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. Feeding problems include mainly vomiting, slow feeding, refusal to eat and colic.

Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory.

Nepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit.

This phase IIa study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days.

The experimental clinical phase encompasses the following periods:

  • Screening period (no study medication), lasting approximately 7 days prior to randomization
  • Treatment period, lasting fourteen days (7 days fore each dose)with once daily administration
  • A safety follow-up visit, approximately four weeks after start of treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Ascending 7 Day-Repeated Dose Study to Investigate Efficacy, Safety and Pharmacokinetics of Nepadutant In Infants With Feeding Intolerance
Study Start Date : August 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Cohort 3
Nepadutant low dose for 7 days followed by Nepadutant high dose for additional 7 days
Drug: Nepadutant
Nepadutant oral solution
Experimental: Cohort 2
Nepadutant medium dose for 7 days followed by Nepadutant high dose for additional 7 days
Drug: Nepadutant
Nepadutant oral solution
Experimental: Cohort 1
Nepadutant low dose for 7 days followed by Nepadutant medium dose for additional 7 days
Drug: Nepadutant
Nepadutant oral solution

Primary Outcome Measures :
  1. Change in Infant Gastroesophageal reflux Questionnaire Revised (I-GERQ-R) score [ Time Frame: one week ]

Secondary Outcome Measures :
  1. Incidence and severity of AEs [ Time Frame: up to 4 weeks ]
  2. Cmax and AUC [ Time Frame: 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose ]

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants with a clinical diagnosis of feeding intolerance.
  • Age ≤ 6 months at the enrolment.
  • Normal growth.
  • Infants who can refrain from use of erythromycin, metoclopramide, antihistaminic drug, proton pump inhibitors (PPIs), antacids, antimuscarinic drugs, simethicone and dimethicone from 1 week prior randomization until end of study.

Exclusion Criteria:

  • Any clinically relevant event (excluding those relevant to the condition under study) which has occurred within one week prior to randomization.
  • Any pharmacological treatment starting within one week prior to randomization.
  • Infants for whom a change in the diet (i.e. weaning) has been performed within one week prior to randomization or is planned during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532518

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Georgia
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States, 30342
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit / University of Louisville
Louisville, Kentucky, United States, 40202
United States, New York
SUNY Downstate Medical Center
Albany, New York, United States, 12207
United States, Ohio
The University of Toledo College of Medicine\The Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
Menarini Group
Principal Investigator: Jeffrey L Blumer, MD, PhD The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA

Responsible Party: Menarini Group Identifier: NCT01532518     History of Changes
Other Study ID Numbers: NIC-04
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Menarini Group:
Feeding intolerance
tachykinin antagonist
Infant colic

Additional relevant MeSH terms:
MEN 11420
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents