Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Recruiting in Palo Alto (17 mi)
+4 other locations
JL
Overseen byJeffrey L Blumer, MD, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Menarini Group
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
JL
Jeffrey L Blumer, MD, PhD
Principal Investigator
The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA
Eligibility Criteria
Inclusion Criteria
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.
Infants with a clinical diagnosis of feeding intolerance.
Age ≤ 6 months at the enrolment.
See 1 more
Treatment Details
Interventions
- Nepadutant (Neurokinin-2 Receptor Antagonist)
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days
Group II: Cohort 2Experimental Treatment1 Intervention
Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days
Group III: Cohort 1Experimental Treatment1 Intervention
Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Center for Digestive HealthcareAtlanta, GA
Arkansas Children's HospitalLittle Rock, AR
SUNY Downstate Medical CenterAlbany, NY
Kosair Charities Pediatric Clinical Research Unit / University of LouisvilleLouisville, KY
More Trial Locations
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Who Is Running the Clinical Trial?
Menarini Group
Lead Sponsor
Trials
45
Patients Recruited
12,600+