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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT01532518
First received: January 25, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Colic
Drug: Nepadutant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Menarini Group:

Primary Outcome Measures:
  • Change in Infant Gastroesophageal reflux Questionnaire Revised (I-GERQ-R) score [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of AEs [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
  • Cmax and AUC [ Time Frame: 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532518

Locations
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
Investigators
Principal Investigator: Jeffrey L Blumer, MD, PhD The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA
  More Information

No publications provided

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01532518     History of Changes
Other Study ID Numbers: NIC-04
Study First Received: January 25, 2012
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014