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NCT01349673 · ClinicalTrials.gov registry record · Phase 3
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
A Phase 3 study, sponsored by Bausch Health Americas.
- Terminated
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
NCT01349673: Clinical Trial Phase 3 study, sponsored by Bausch Health Americas.
NCT01349673 is a Phase 3 study that was terminated before completion, run by Bausch Health Americas. The registered enrollment target is 114 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349673, a Phase 3 study, was terminated before completion, sponsored by Bausch Health Americas.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
Primary Outcome
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Interventions
- DRUG Budesonide Foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2011-05-31 |
| Est. Completion | 2014-12-31 |
| Phase | Phase 3 |
Why NCT01349673 stopped before completion
NCT01349673 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Budesonide Foam is the first listed.
NCT01349673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349673 about?
NCT01349673 is a clinical study titled "The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis". The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
What is the current status of trial NCT01349673?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2011-05-31. Estimated completion is 2014-12-31.
What interventions are being tested in trial NCT01349673?
The interventions under investigation include: Budesonide Foam (DRUG).
Who is sponsoring clinical trial NCT01349673?
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 NCT01349673's enrollment target sits among peer trials
114 1648th of 2000 higher than 350 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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