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

Phase 1

Completed

• Conditions: Infantile Colic; Infantile Functional Gastrointestinal Disorders
• Interventions: Drug: Nepadutant

• Registration Number: NCT00655083
• Lead Sponsor: Menarini Group

Brief 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.

Detailed Description

This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.

Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-05-27
• Results First Submitted QC: 2010-08-03
• Results First Posted: 2010-08-25
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-11
• Last Update Posted: 2011-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Subjects will be eligible for inclusion in the study if they meet all of the following criteria:

• Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders
• Age >6 weeks and < 24 weeks
• At least 44 weeks post-conceptual age at enrolment
• Normal growth
• Informed consent by parents (one or both) or legal guardian
• Caregiver available to be trained in collection and storage of used diapers
• Caregiver available to record feeding episodes and defecations on the diary

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following criteria:

• Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;
• Previous major surgery or blood loss
• Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nepadutant	Nepadutant 0.1 mg/kg
2	Nepadutant	Nepadutant 0.5 mg/kg

Primary Outcome Measures

Name	Time	Method
Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.	24 hours	Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.	one week	Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.

Trial Locations

Locations (3)

Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States