Last updated on January 2019

Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

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Brief description of study

This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)

Detailed Study Description

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (PK) parameters of plecanatide of once daily oral 3 dose levels of plecanatide (0.5, 1.0, or 1.5 mg) for 4 weeks as treatment in children 6 to <18 years of age with IBS-C.

The study will include a 28-day Screening/Baseline Period, a 4 week treatment period, and a 2-week post-treatment follow-up period. Patients/caregivers will visit the clinic 4 times during the study.