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

Summary

The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to \<18 years. The main questions it aims to answer are: * Does plecanatide increase the number of spontaneous bowel movements (SBMs) compared to placebo? * Is plecanatide safe and well tolerated in this pediatric population? Researchers will compare plecanatide at different doses to a placebo (a look-alike substance with no active drug) to see if plecanatide improves bowel function. Participants will: * Take plecanatide or placebo orally once daily for 4 weeks * Complete daily symptom diaries * Attend clinic visits for assessments and safety checks

Timeline

Start

2018-06-30

Primary completion

2024-11-25

Completion

2024-11-25

Drugs

Indications