NCT00887263CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 186
- Locations
- 2
- Primary Endpoint
- Rate of patients with objective response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Experimental
Intervention: Budesonide (Drug)
B
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Rate of patients with objective response
Time Frame: 12 weeks
Secondary Outcomes
- Rate of complete/partial response, stable disease, progressive disease(12 weeks)
- Time to initial objective response(x weeks)
- Rate of subjective improvement(12 weeks)
Investigators
Study Sites (2)
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