Clinical trial

A Multicenter, Open Label, Ascending 7 Day-Repeated Dose Study to Investigate Efficacy, Safety and Pharmacokinetics of Nepadutant In Infants With Feeding Intolerance

Name

NIC-04

Description

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.

Trial arms

Trial start

2011-08-01

Estimated PCD

2012-07-01

Trial end

2012-07-01

Status

Completed

Phase

Early phase I

Treatment

Nepadutant

Nepadutant oral solution

Arms:

Cohort 1, Cohort 2, Cohort 3

Other names:

MEN 11420

Size

Primary endpoint

The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2).

Baseline (V2) and end of first week of treatment (V3)

The Absolute Differences of I-GERQ-R Total Score at V4 (End of 2nd Week of Treatment) Respect to V3 (End of 1st Week of Treatment).

V3 (end of 1st week of treatment) and V4 (end of 2nd week of treatment)

The Absolute Differences of I-GERQ-R Total Score at V5 (Follow-up) Respect to V2 (Baseline).

Baseline (V2) and follow up 2 weeks after the last administered dose (V5)

I-GERQ-R Score Changes vs Baseline (Visit 2) by First Dose Level (0.1mg/kg and 0.5mg/kg).

Baseline (V2) and end of 1st week of treatment(V3)

I-GERQ-R Score Changes vs Visit 3 by Second Dose Level (0.5mg/kg and 1mg/kg).

end of first week of treatment (V3) and end of second week of treatment (V4)

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

Updated at

2023-05-06

1 organization

1 product

1 indication

Organization

Menarini Group

Product

Nepadutant

Indication

Colic