NCT01349673

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

A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day \[BID\] for 2 weeks and once daily \[QD\] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Conditions

• Proctitis
• Proctosigmoiditis

Interventions

Type	Name	Description
DRUG	Budesonide Foam	Topical

Timeline

• Start date: 2011-05-31
• Primary completion: 2014-12-31
• Completion: 2014-12-31
• First posted: 2011-05-06
• Last updated: 2019-08-14
• Results posted: 2019-08-14

Locations

1 site across 1 country: United States