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NCT01722318 · ClinicalTrials.gov registry record · Phase 2
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 428
- Enrollment target
NCT01722318: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT01722318 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 428 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (222% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722318, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 428 participants
- Enrollment target
Study Summary
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
Primary Outcome
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.
Interventions
- DRUG Placebo
- DRUG Plecanatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01722318 record still lists
NCT01722318 is an interventional study that assigns participants to a tested intervention. The registered 428 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 (222% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01722318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01722318 about?
NCT01722318 is a clinical study titled "The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)". This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
What is the current status of trial NCT01722318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 428 participants. The study started on 2012-11. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01722318?
The interventions under investigation include: Placebo (DRUG), Plecanatide (DRUG).
Who is sponsoring clinical trial NCT01722318?
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 NCT01722318's enrollment target sits among peer trials
428 91st of 2000 higher than 1,910 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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