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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 is a Phase 3 study that was terminated before completion, run by Bausch Health Americas. The registered enrollment target is 114 participants.

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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).

Interventions

  • DRUG Budesonide Foam

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2011-05-31
Est. Completion 2014-12-31
Phase Phase 3

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT01349673

The ClinicalTrials.gov registry entry for NCT01349673 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 114 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 1 intervention - of which Budesonide Foam is the first listed.

NCT01349673 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.