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

Completed · Phase 2

Conditions studied: Colic

In brief

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.

Key facts

Study ID

NCT01532518

Run by

Menarini Group

People needed

27

Starts

2011-08-01

Expected to finish

2012-07-01

Last updated by the study team

2023-05-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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