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NCT01919697 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,370
- Enrollment target
NCT01919697: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT01919697 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 2,370 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (207% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01919697, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,370 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Primary Outcome
All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.
Interventions
- DRUG Plecanatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,370 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
What the finished NCT01919697 record still lists
NCT01919697 is an interventional study that assigns participants to a tested intervention. Its 2,370 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (207% higher).
The record links to 0 conditions, and to 1 intervention - of which Plecanatide is the first listed.
NCT01919697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01919697 about?
NCT01919697 is a clinical study titled "Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)". This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
What is the current status of trial NCT01919697?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,370 participants. The study started on 2013-08. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01919697?
The interventions under investigation include: Plecanatide (DRUG).
Who is sponsoring clinical trial NCT01919697?
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 NCT01919697's enrollment target sits among peer trials
2,370 91st of 2000 higher than 1,910 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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