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A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants

NCT00655083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2011-10-17

Study results available
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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.

Conditions

  • Infantile Colic
  • Infantile Functional Gastrointestinal Disorders

Interventions

DRUG

Nepadutant

0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)

DRUG

Nepadutant

0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Jeffrey L Blumer, MD, PHD · Rainbow Babies and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
24 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00655083 on ClinicalTrials.gov