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

January 20, 2016 updated by: Dr. Falk Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93053
        • University of Regensburg
  • Israel
      • Jerusalem, Israel, 91120
        • The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Karnofsky >= 70
  • Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation
  • Oral cGvHD of erosive and/or ulcerative type
  • NIH scale >= 3
  • Resistant oral cGvHD with no oral response to conventional primary treatment

Exclusion Criteria:

  • Uncertain diagnosis of resistant oral cGvHD
  • Symptomatic oral cGvHD of hyperkeratotic type solely
  • Current active oral bacterial, viral, or fungal infection
  • Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain
  • Requiring addition of new systemic therapy including steroids, or radiation therapy
  • Local intestinal infection
  • Abnormal hepatic function or liver cirrhosis
  • If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection
  • Second line treatment of oral cGvHD with topical steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Budesonide
3 mg TID
Placebo Comparator: B
Drug: Placebo
0 mg TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with objective response
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of complete/partial response, stable disease, progressive disease
Time Frame: 12 weeks
12 weeks
Time to initial objective response
Time Frame: x weeks
x weeks
Rate of subjective improvement
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Sharon Elad, DMD, University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUM-5/GVH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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