Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Change in Infant Gastroesophageal reflux Questionnaire Revised (I-GERQ-R) score [ Time Frame: one week ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 26 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 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 |
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| 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 | |
| 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: | July 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Menarini Group:
|
Feeding intolerance Infant tachykinin antagonist Infant colic Nepadutant |
Additional relevant MeSH terms:
|
Colic Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive MEN 11420 Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013