Status:
COMPLETED
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Lead Sponsor:
Menarini Group
Conditions:
Infantile Colic
Infantile Functional Gastrointestinal Disorders
Eligibility:
All Genders
6-24 years
Phase:
PHASE1
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 e...
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 absorpt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00655083
Start Date
March 1 2008
End Date
May 1 2009
Last Update
October 17 2011
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
Louisville, Kentucky, United States, 40202
3
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106