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NCT01008423 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 281
- Enrollment target
NCT01008423 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 281 participants.
The verdict
NCT01008423, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 281 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
Interventions
- DRUG Placebo
- DRUG Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2009-11-20 |
| Est. Completion | 2013-03-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01008423
The ClinicalTrials.gov registry entry for NCT01008423 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 281 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 Placebo is the first listed.
NCT01008423 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01008423 about?
NCT01008423 is a clinical study titled "Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis". The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proct...
What is the current status of trial NCT01008423?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 2009-11-20. Estimated completion is 2013-03-18.
What interventions are being tested in trial NCT01008423?
The interventions under investigation include: Placebo (DRUG), Budesonide (DRUG).
Who is sponsoring clinical trial NCT01008423?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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