At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Nepadutant +1 moredrug
Likely dose
Nepadutant 0.1 mg/Kgfrom 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.
Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic and Other Functional Gastrointestinal Disorders
In Brief
A Phase 1 clinical trial evaluating Nepadutant for Infantile Colic and Infantile Functional Gastrointestinal Disorders. Completed, enrolled 21 participants across 3 sites.
Detailed Summary
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedApr 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedApr 9, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.2 years ago
Interventions
Nepadutantdrug
0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Nepadutantdrug
0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)