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

January 25, 2012
March 24, 2014
August 2011
July 2012   (final data collection date for primary outcome measure)
Change in Infant Gastroesophageal reflux Questionnaire Revised (I-GERQ-R) score [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01532518 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
A Multicenter, Open Label, Ascending 7 Day-Repeated Dose Study to Investigate Efficacy, Safety and Pharmacokinetics of Nepadutant In Infants With Feeding Intolerance

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colic
Drug: Nepadutant
Nepadutant oral solution
  • Experimental: Cohort 3
    Nepadutant low dose for 7 days followed by Nepadutant high dose for additional 7 days
    Intervention: Drug: Nepadutant
  • Experimental: Cohort 2
    Nepadutant medium dose for 7 days followed by Nepadutant high dose for additional 7 days
    Intervention: Drug: Nepadutant
  • Experimental: Cohort 1
    Nepadutant low dose for 7 days followed by Nepadutant medium dose for additional 7 days
    Intervention: Drug: Nepadutant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01532518
NIC-04
No
Menarini Group
Menarini Group
Not Provided
Principal Investigator: Jeffrey L Blumer, MD, PhD The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA
Menarini Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP