At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
Nepadutantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open Label, Ascending 7 Day-Repeated Dose Study to Investigate Efficacy, Safety and Pharmacokinetics of Nepadutant In Infants With Feeding Intolerance
In Brief
A Phase 2 clinical trial evaluating Nepadutant for Colic. Completed, enrolled 27 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColic
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedFeb 2012
Primary CompletionJul 2012
TodayJul 2026
First PostedFeb 14, 2012
Enrollment StartAug 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.4 years ago
Interventions
Nepadutantdrug
Nepadutant oral solution