Constipation Treatment with Linaclotide – Phase II

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

Protocol Description

The purpose of this multi-center research study is to evaluate the effectiveness and safety of linaclotide for children with functional constipation or chronic constipation that does not have a structural or biochemical explanation. Linaclotide is approved for use in adults for treatment of constipation, but has not previously been studied in children.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting patients of both genders, ages 6 through 17 years, who have met the modified Rome III criteria for Child/adolescent functional constipation for at least two months.
Boys and Girls: Ages 6 through 17 years

Requirements

Following a 4-week screening period and 2- to 3-week pretreatment period, participants will be randomly assigned to receive either the linaclotide study drug or a placebo to take by mouth once a day for 4 weeks. Participants age 6 to 11 will take a liquid solution, and older participants will take either a capsule or liquid solution. During study visits, patients will receive physicals, testing, and instructions on lifestyle modifications to help treat constipation.
Visits: 6
Duration: About 12 weeks

Status: Open to Enrollment

Source(s) of Support

Forest Research Institute

Primary Investigator

Arvind I. Srinath, MD

Contact Information

For more information about the study or enrollment, please contact:
Amy Bookser, RN
412-692-8453