Back to resultsA Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Primary Purpose
Infantile Colic, Infantile Functional Gastrointestinal Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nepadutant
Nepadutant
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Colic focused on measuring Infantile colic, Abdominal Cramps, Colicky Pain, Functional gastrointestinal disorders
Eligibility Criteria
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.
Sites / Locations
- Arkansas Children's Hospital
- Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
- Rainbow Babies and Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Nepadutant 0.1 mg/kg
Nepadutant 0.5 mg/kg
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655083
Brief Title
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic, Infantile Functional Gastrointestinal Disorders
Keywords
Infantile colic, Abdominal Cramps, Colicky Pain, Functional gastrointestinal disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nepadutant 0.1 mg/kg
Arm Title
2
Arm Type
Experimental
Arm Description
Nepadutant 0.5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Nepadutant
Intervention Description
0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Intervention Type
Drug
Intervention Name(s)
Nepadutant
Intervention Description
0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 hours
Title
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.
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
Description
Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.
Time Frame
one week
Title
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
Description
Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
24 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Blumer, MD, PHD
Organizational Affiliation
Rainbow Babies and Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
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