Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03596905 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 218
- Enrollment target
NCT03596905 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 218 participants.
The verdict
NCT03596905, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 218 participants
- Enrollment target
Study 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
Interventions
- DRUG Matching placebo
- DRUG Plecanatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2018-06-30 |
| Est. Completion | 2024-11-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03596905
The ClinicalTrials.gov registry entry for NCT03596905 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT03596905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03596905 about?
NCT03596905 is a clinical study titled "Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)". 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 spon...
What is the current status of trial NCT03596905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 218 participants. The study started on 2018-06-30. Estimated completion is 2024-11-25.
What interventions are being tested in trial NCT03596905?
The interventions under investigation include: Matching placebo (DRUG), Plecanatide (DRUG).
Who is sponsoring clinical trial NCT03596905?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.