Clinical Trial: The Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is to evaluate safety and tolerability of cyclically dosed rectal budesonide foam in subjects with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Detailed Summary: This is a Phase 3, multicenter, open label study in subjects who have participated previously in a Salix-sponsored budesonide rectal foam study for the treatment of ulcerative proctitis or proctosigmoiditis. Approximately 300 subjects will be enrolled into the study and receive budesonide foam cyclically for 6 weeks (BID for 2 weeks and QD for 4 weeks) each time they have an ulcerative proctitis or proctosigmoiditis flare. The study will continue until regulatory approval of budesonide foam occurs, or the sponsor decides to terminate the study.
Sponsor: Valeant Pharmaceuticals International, Inc.

Current Primary Outcome: To evaluate safety and tolerability of cyclically dosed rectal budesonide foam in subjects who present with a diagnosis of active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). [ Time Frame: 6 weeks ]

The following safety endpoints will be assessed throughout the study for each treatment group:

  • Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), grouped by body system, relationship to study medication, and severity.
  • Changes from baseline in clinical laboratory assessments: urinalysis, hematology, and clinical chemistry.
  • Changes from baseline in vital sign assessments.
  • Changes from baseline in physical examination findings.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: May 4, 2011
Date Started: June 2011
Date Completion:
Last Updated: January 26, 2015
Last Verified: January 2015