Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
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.
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
- Enrollment
- 218 participants
Conditions and interventions
Conditions
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.