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

Phase 3

Completed

• Conditions: Oral Chronic Graft vs Host Disease
• Interventions: Drug: Placebo; Drug: Budesonide

• Registration Number: NCT00887263
• Lead Sponsor: Dr. Falk Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	-
A	Budesonide	-

Primary Outcome Measures

Name	Time	Method
Rate of patients with objective response	12 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of complete/partial response, stable disease, progressive disease	12 weeks
Time to initial objective response	x weeks
Rate of subjective improvement	12 weeks

Trial Locations

Locations (2)

University of Regensburg; 🇩🇪 Regensburg, Germany

The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine; 🇮🇱 Jerusalem, Israel