Offered by: Nemours
Location: Jacksonville, Fla.
Safety and Efficacy Study of Linaclotide Administered to Children, with Functional Constipation
What is the trial about?
The purpose of this study is to pursue approval of Linaclotide by the FDA so that physicians have a medication to use for functional constipation. There are no approved products for functional constipation in children. Effective treatments are needed to provide symptomatic relief in children.
Who can participate?
Males and females between 6-17 years of age. Children must weigh over 39.6 pounds. Two or less bowel movements per week. Must be toilet trained.
What is involved?
Children will participate in this study for 20 weeks. There will be 8 visits within the 20 weeks. Visits can be any where from 2 weeks to 4 weeks apart. At the end of this study your child could enroll in the extension study which will be 6 months longer.
Contact Nemours Clinical Trials
Trial Name: Safety and Efficacy Study of Linaclotide Administered to Children, with Functional Constipation