MedTrace Logo

Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

NCT01258153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2015-06-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Infantile Colic

Interventions

DRUG

Nepadutant oral solution

Oral administration once daily for 7 days

DRUG

Nepadutant oral solution

Oral administration once daily for 7 days

DRUG

Placebo matching Nepadutant oral solution

Oral administration once daily for 7 days

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Sibylle Koletzko, MD · Dr. v. Haunersches Kinderspital Ludwig Maximilians University D- 80337 München, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
20 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • Germany
  • Poland
  • Russia
  • Sweden

Study Locations

More Related Trials

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 NCT01258153 on ClinicalTrials.gov