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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03596905

Public ClinicalTrials.gov record NCT03596905. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 5:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT03596905
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
218 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 29, 2018
Primary completion
Nov 24, 2024
Completion
Nov 24, 2024
Last update posted
Dec 30, 2025

2018 – 2024

United States locations

U.S. sites
35
U.S. states
17
U.S. cities
31
Facility City State ZIP Site status
Bausch Site 178 Saraland Alabama 36571
Bausch Site 176 Scottsdale Arizona 85258
Bausch Site 160 Corona California 92879
Bausch Site 147 Garden Grove California 92845
Bausch Site 142 Los Angeles California 90036
Bausch Site 143 Ventura California 93003
Bausch Site 175 Aurora Colorado 80012
Bausch Site 197 Washington D.C. District of Columbia 20016
Bausch Site 135 Doral Florida 33122
Bausch Site 190 Hialeah Florida 33012
Bausch Site 150 Miami Florida 33126
Bausch Site 130 Miami Florida 33134
Bausch Site 165 Miami Florida 33136
Bausch Site 110 Tampa Florida 33607
Bausch Site 174 Atlanta Georgia 30315
Bausch Site 132 Atlanta Georgia 30342
Bausch Site 148 Stockbridge Georgia 30281
Bausch Site 115 Evansville Indiana 47715
Bausch Site 139 Sioux City Iowa 51106
Bausch Site 192 Bowling Green Kentucky 42101
Bausch Site 172 Covington Louisiana 70433
Bausch Site 180 Crowley Louisiana 70526
Bausch Site 112 Lafayette Louisiana 70508
Bausch Site 220 Omaha Nebraska 68134
Bausch Site 145 Akron Ohio 44308
Bausch Site 194 Cleveland Ohio 44106
Bausch Site 111 Knoxville Tennessee 37922
Bausch Site 195 Austin Texas 78723
Bausch Site 225 Cedar Park Texas 78613
Bausch Site 173 Dallas Texas 75243
Bausch Site 193 Houston Texas 77030
Bausch Site 170 Houston Texas 77087
Bausch Site 140 San Antonio Texas 78215
Bausch Site 120 Newport News Virginia 23606
Bausch Site 146 Bellevue Washington 98007

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03596905, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 30, 2025 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03596905 live on ClinicalTrials.gov.

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