Functional Constipation in Children Ages 6-17 Years Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
The purpose of this study was to evaluate dose response of the safety and efficacy of
linaclotide for the treatment of functional constipation (FC), in children age 6-17 years.
This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.
Participants age 6-11 years will receive oral liquid formulation and participants 12-17 years
will receive solid oral capsule or liquid oral solution.
Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of
linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will
be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.
This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well
as other bowel symptoms of FC.
n/a