Status:
COMPLETED
Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Oral Chronic Graft vs Host Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00887263
Start Date
March 1 2009
End Date
October 1 2015
Last Update
January 21 2016
Active Locations (2)
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1
University of Regensburg
Regensburg, Germany, 93053
2
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine
Jerusalem, Israel, 91120