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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
186
3 mg TID
0 mg TID
University of Regensburg
Regensburg, Germany
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine
Jerusalem, Israel
Rate of patients with objective response
Time frame: 12 weeks
Rate of complete/partial response, stable disease, progressive disease
Time frame: 12 weeks
Time to initial objective response
Time frame: x weeks
Rate of subjective improvement
Time frame: 12 weeks
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