Awardee OrganizationCASE WESTERN RESERVE UNIVERSITY
Description
Abstract Text
In the pediatric population, constipation is the chief complaint in about 3% of all pediatric outpatient visits; as many as 25% of referrals to pediatric gastroenterologists are for children with constipation. The majority of these children have a form of functional constipation, referred to as FFR or functional fecal retention. The primary objective of this trial is to characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in pediatric subjects aged greater than 4 to less than 12 years with FFR. This dose corresponds to an adult dose of .15 - 2.0 mg of prucalopride. The secondary objective is to evaluate the safety and the tolerability (adverse experiences) of a single oral dose of prucalopride solution, 0.03 mg/kg, given to pediatric subjects with FFR. No efficacy will be evaluated in this trial. Pharmacokinetic studies were done on the GCRC.
No Sub Projects information available for 5M01RR000080-38 0975
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 5M01RR000080-38 0975
Patents
No Patents information available for 5M01RR000080-38 0975
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 5M01RR000080-38 0975
Clinical Studies
No Clinical Studies information available for 5M01RR000080-38 0975
News and More
Related News Releases
No news release information available for 5M01RR000080-38 0975
History
No Historical information available for 5M01RR000080-38 0975
Similar Projects
No Similar Projects information available for 5M01RR000080-38 0975