This study is to determine the pharmacokinetics of a new drug for the treatment of constipation in children. The purpose of the study is to determine the preliminary safety and efficacy of a single dose of 0.03 mg/kg prucalopride (R108512) in pediatric subjects aged <4 to >12 years with functional fecal retention. This dose corresponds to an adult dose of 1.5-2.0 mg of prucalopride.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001066-23
Application #
6409598
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-02-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
23
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199
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