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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 Oct 23, 2026, 2:34 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 30, 2018 (Actual)
Primary completion
Nov 25, 2024 (Actual)
Completion
Nov 25, 2024 (Actual)
Last update posted
Dec 31, 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 31, 2025 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03596905 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →