Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

Oral Chronic Graft vs Host Disease Clinical Trial

Official title: Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD

Status Completed

Clinical Trial Summary

The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Oral Chronic Graft vs Host Disease

• NCT number: NCT00887263
• Study type: Interventional
• Source: Dr. Falk Pharma GmbH
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Completion date: October 2015