Phase 2
N=27
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Colic
Bottom Line
View on ClinicalTrials.gov: NCT01532518 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
May 2023
Primary outcome: Primary: The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2). — -6.8; -7.6; -6.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nepadutant (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Menarini Group
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2). |
-6.8; -7.6; -6.8 | — |
| PRIMARY The Absolute Differences of I-GERQ-R Total Score at V4 (End of 2nd Week of Treatment) Respect to V3 (End of 1st Week of Treatment). |
-15.2; -11.9; -8.6 | — |
| PRIMARY The Absolute Differences of I-GERQ-R Total Score at V5 (Follow-up) Respect to V2 (Baseline). |
-7.8; -11.1; -9.8 | — |
| PRIMARY I-GERQ-R Score Changes vs Baseline (Visit 2) by First Dose Level (0.1mg/kg and 0.5mg/kg). |
-6.8; -7.6 | — |
| PRIMARY I-GERQ-R Score Changes vs Visit 3 by Second Dose Level (0.5mg/kg and 1mg/kg). |
-1.4; -4.9 | — |
| SECONDARY Incidence and Severity of AEs_ Number of Adverse Events by Treatment Dose Level |
6; 4; 3; 1; 0; 0 | — |
| SECONDARY A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 |
0.0275; 0.0342; 0.0346 | — |
| SECONDARY A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 |
0.0275; 0.0342; 0.0346 | — |
| SECONDARY A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 |
0.0275; 0.0342; 0.0346 | — |
| SECONDARY A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 |
0.0275; 0.0342; 0.0346 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01532518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.