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

Infantile Colic Clinical Trial

Official title:

Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic and Other Functional Gastrointestinal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655083
• Other study ID #: NIC 02
• Secondary ID: Oral absorptiono
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2008
• Last updated: October 11, 2011
• Start date: March 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2011
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 24 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Digestive System Diseases
• Gastrointestinal Diseases
• Infantile Colic
• Infantile Functional Gastrointestinal Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.	24 hours	No
Primary	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.	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.	24 hours	No
Secondary	Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.	Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.	one week	Yes
Secondary	Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.	Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.	one week	Yes