Constipation in Patients with IBS Treated with Linaclotide – Phase II

Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 7 to 17 Years with Irritable Bowel Syndrome with Constipation

Protocol Description

The purpose of this multi-center research study is to evaluate the effectiveness and safety of linaclotide for the treatment of irritable bowel syndrome (IBS) with constipation in children. 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 7 through 17 years, who have met the modified Rome III criteria for IBS for at least 2 months prior to the initial screening visit.
Boys and Girls: Ages 7 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