A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Completed · Phase 1
Conditions studied: Infantile Colic, Infantile Functional Gastrointestinal Disorders
In brief
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.
Key facts
- Study ID
- NCT00655083
- Run by
- Menarini Group
- People needed
- 21
- Starts
- 2008-03-01
- Expected to finish
- 2009-05-01
- Last updated by the study team
- 2011-10-17
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville — Louisville, Kentucky, United States
- Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.