drugset / Trial / NCT01309009

Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment

NCT01309009 ↗

Phase 2 Withdrawn Menarini Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This phase IIa study is designed as a multi-centre, single country, 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.

Timeline

Start
2011-02
Primary completion
2012-11
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nepadutant Protein / enzyme biologic — Oral

Indications