drugset / Trial / NCT01349673

The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

NCT01349673 ↗

Phase 3 Terminated 114 enrolled Bausch Health Americas, Inc.
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2011-05-31
Primary completion
2014-12-31
Completion
2014-12-31

Outcome

Outcome not reported

Stopped: “Terminated for non-safety reasons when Sponsor felt that sufficient long-term safety data was obtained.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 2 mg Rectal

Indications