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Efficacy and Safety of Budesonide Foam for Patients With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

2014-08-27 03:18:10 | BioPortfolio

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of budesonide foam in subjects with active mild to moderate proctitis or proctosigmoiditis.

Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of budesonide foam in subjects with active mild to moderate proctitis or proctosigmoiditis. Approximately 430 subjects will be enrolled into the study and receive either placebo foam or budesonide foam twice a day for 2 weeks followed by once a day for 4 weeks.

Participation in the study will last approximately 11 weeks, depending on the timing of study visits. Periodic safety monitoring, including physical examinations, vitals, laboratory testing, and recording of AEs and concomitant medications, will be performed during the study.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Proctitis

Intervention

Budesonide, Placebo

Location

Birmingham
Alabama
United States

Status

Recruiting

Source

Salix Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:10-0400

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