A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
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
3 other identifiers
interventional
21
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
August 25, 2010
CompletedOctober 17, 2011
October 1, 2011
1.2 years
April 3, 2008
May 27, 2010
October 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
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 After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
one week
Study Arms (2)
1
EXPERIMENTALNepadutant 0.1 mg/kg
2
EXPERIMENTALNepadutant 0.5 mg/kg
Interventions
0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Menarini Grouplead
Study Sites (3)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
Louisville, Kentucky, 40202, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No infants aged 18-24 weeks were dosed at 0.5 mg/kg dose when the trial was stopped because of slow recruitment and drug expiration.
Results Point of Contact
- Title
- Angela Capriati, Clinical research Director
- Organization
- Menarini Group- Clinical Research
Study Officials
- STUDY CHAIR
Jeffrey L Blumer, MD, PHD
Rainbow Babies and Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 9, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 17, 2011
Results First Posted
August 25, 2010
Record last verified: 2011-10