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

NCT ID: NCT01532518

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 3

Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days

Group Type: EXPERIMENTAL

Nepadutant

Intervention Type: DRUG

Nepadutant oral solution

Cohort 2

Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days

Group Type: EXPERIMENTAL

Nepadutant

Intervention Type: DRUG

Nepadutant oral solution

Cohort 1

Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days

Group Type: EXPERIMENTAL

Nepadutant

Intervention Type: DRUG

Nepadutant oral solution

Interventions

Nepadutant

Nepadutant oral solution

Intervention Type: DRUG

Other Intervention Names

MEN 11420

Eligibility Criteria

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.

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey L Blumer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

Kosair Charities Pediatric Clinical Research Unit / University of Louisville

Louisville, Kentucky, United States

SUNY Downstate Medical Center

Albany, New York, United States

The University of Toledo College of Medicine\The Toledo Children's Hospital

Toledo, Ohio, United States

Countries

United States

Other Identifiers

NIC-04

Identifier Type: -

Identifier Source: org_study_id