At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 115 enrolled
Drug / intervention
Nepadutant oral solution +2 moredrug
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.
Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic
In Brief
A Phase 2 clinical trial evaluating Nepadutant oral solution and Placebo matching Nepadutant oral solution for Infantile Colic. Completed, enrolled 115 participants across 9 sites in 4 countries.
Detailed Summary
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfantile Colic
CountriesGermany, Poland, Russia, Sweden
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedDec 2010
Primary CompletionDec 2013
Study CompletionMar 2014
TodayJul 2026
First PostedDec 10, 2010
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.6 years ago
Interventions
Nepadutant oral solutiondrug
Oral administration once daily for 7 days
Nepadutant oral solutiondrug
Oral administration once daily for 7 days
Placebo matching Nepadutant oral solutiondrug
Oral administration once daily for 7 days