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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: MEN 11420

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.