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

Oral Chronic Graft vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887263
• Other study ID #: BUM-5/GVH
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2009
• Last updated: January 20, 2016
• Start date: March 2009
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Oral Chronic Graft vs Host Disease

Intervention

Drug:
• Budesonide
3 mg TID
• Placebo
0 mg TID

Locations

Country	Name	City	State
Germany	University of Regensburg	Regensburg
Israel	The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Countries where clinical trial is conducted

Germany,  Israel, 

References & Publications (1)

Elad S, Or R, Garfunkel AA, Shapira MY. Budesonide: a novel treatment for oral chronic graft versus host disease. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Mar;95(3):308-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with objective response		12 weeks	No
Secondary	Rate of complete/partial response, stable disease, progressive disease		12 weeks	No
Secondary	Time to initial objective response		x weeks	No
Secondary	Rate of subjective improvement		12 weeks	No