Clinical trial NCT00655083: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infantile Colic
Infantile Functional Gastrointestinal Disorders
Keywords: Infantile colic
Abdominal Cramps
Colicky Pain
Functional gastrointestinal disorders
Lead sponsor: Menarini Group
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 24 hours
measure: 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.
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
timeFrame: one week
measure: Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
timeFrame: one week
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
state: Kentucky
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: Rainbow Babies and Children's Hospital
name: Jeffrey L Blumer, MD, PHD
role: STUDY_CHAIR
References: