A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Infantile ColicInfantile Functional Gastrointestinal Disorders
Interventions
DRUG

Nepadutant

0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)

DRUG

Nepadutant

0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)

Trial Locations (3)

40202

Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville, Louisville

44106

Rainbow Babies and Children's Hospital, Cleveland

72202

Arkansas Children's Hospital, Little Rock

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY

NCT00655083 - A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants | Biotech Hunter | Biotech Hunter