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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: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT03596905 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 218 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Weekly SBM rate computed for each week
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 |
What the finished NCT03596905 record still lists
NCT03596905 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT03596905 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03596905's enrollment target sits among peer trials
218 284th of 2000 higher than 1,715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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