Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)
NCT ID: NCT00887263
Last Updated: 2016-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
186 participants
INTERVENTIONAL
2009-03-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Budesonide
3 mg TID
B
Placebo
0 mg TID
Interventions
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Budesonide
3 mg TID
Placebo
0 mg TID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Sharon Elad, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health
Locations
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University of Regensburg
Regensburg, , Germany
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine
Jerusalem, , Israel
Countries
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References
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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. doi: 10.1067/moe.2003.23.
Elad S, Zeevi I, Finke J, Koldehoff M, Schwerdtfeger R, Wolff D, Mohrbacher R, Levitt M, Greinwald R, Shapira MY. Improvement in oral chronic graft-versus-host disease with the administration of effervescent tablets of topical budesonide-an open, randomized, multicenter study. Biol Blood Marrow Transplant. 2012 Jan;18(1):134-40. doi: 10.1016/j.bbmt.2011.06.001. Epub 2011 Jun 12.
Other Identifiers
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BUM-5/GVH
Identifier Type: -
Identifier Source: org_study_id
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