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

NCT01309009 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-11-06

No results posted yet for this study

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.

Conditions

  • Infantile Colic

Interventions

DRUG

Nepadutant oral solution

Oral administration once daily for 7 days

DRUG

Placebo matching Nepadutant oral solution

Oral administration once daily for 7 days

DRUG

Nepadutant oral solution

Oral administration once daily for 7 days

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Paolo Lionetti, MD · Servizio di Gastroenterologia dell'Azienda Ospdedaliero - Universitaria Anna Meyer di Firenze

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-11-30
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01309009 on ClinicalTrials.gov