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

This study is currently recruiting participants.

Verified by Dr. Falk Pharma GmbH, April 2009

First Received: April 22, 2009 No Changes Posted

Sponsored by:	Dr. Falk Pharma GmbH
Information provided by:	Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00887263

Purpose

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.

Condition	Intervention	Phase
Oral Chronic Graft vs Host Disease	Drug: Budesonide Drug: Placebo	Phase III

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:

Rate of patients with objective response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of complete/partial response, stable disease, progressive disease [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to initial objective response [ Time Frame: x weeks ] [ Designated as safety issue: No ]
Rate of subjective improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	126
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Budesonide 3 mg TID
B: Placebo Comparator	Drug: Placebo 0 mg TID

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887263

Contacts

Contact: Ralf Mohrbacher, MSc	++49 761 1514-0 ext 156	mohrbacher@drfalkpharma.de
Contact: Daniel Wolff, MD	++49 941 944-0 ext 5531	daniel.wolff@klinik.uni-regensburg.de

Locations

Germany
University of Regensburg	Recruiting
Regensburg, Germany, 93053
Contact: Daniel Wolff, MD ++49 941 944-0 ext 5531 daniel.wolff@klinik.uni-regensburg.de
Principal Investigator: Daniel Wolff, MD
Israel
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine	Not yet recruiting
Jerusalem, Israel, 91120
Contact: Sharon Elad, DMD ++972 2 6777735 sharonela@ekmd.huji.ac.il
Principal Investigator: Sharon Elad, DMD

Sponsors and Collaborators

Dr. Falk Pharma GmbH

Investigators

Principal Investigator:

Sharon Elad, DMD

The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine

More Information

Publications:

Elad S, Or R, Garfunkel AA, Shapira MY. Budesonide: a novel treatment for oral chronic graft versus host disease. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Mar;95(3):308-11.

Responsible Party:	Dr. Falk Pharma GmbH ( Dr. Falk Pharma GmbH )
Study ID Numbers:	BUM-5/GVH
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00887263 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Anti-Inflammatory Agents
Graft Versus Host Disease
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents

Graft vs Host Disease
Peripheral Nervous System Agents
Hormones
Glucocorticoids
Bronchodilator Agents
Homologous Wasting Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Graft vs Host Disease
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 06, 2009