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

Dr. Falk Pharma

Status and phase: Completed; Phase 3

Conditions: Oral Chronic Graft vs Host Disease

Treatments: Drug: Placebo; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887263

BUM-5/GVH

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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186 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Budesonide

B

Placebo Comparator group

Treatment:

Drug: Placebo