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

NCT03596905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-12-31

Study results available
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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

Conditions

  • Irritable Bowel Syndrome With Constipation

Interventions

DRUG

Plecanatide

Taken orally daily for 4 weeks

DRUG

Matching placebo

Taken orally daily for 4 weeks

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2024-11-25
Completion
2024-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596905 on ClinicalTrials.gov