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

Primary Purpose

Oral Chronic Graft vs Host Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Budesonide

Placebo

About this trial

This is an interventional treatment trial for Oral Chronic Graft vs Host Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Regensburg
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients with objective response

Secondary Outcome Measures

Rate of complete/partial response, stable disease, progressive disease

Time to initial objective response

Rate of subjective improvement

Full Information

NCT ID

NCT00887263

First Posted

April 22, 2009

Last Updated

January 20, 2016

Sponsor

Dr. Falk Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00887263

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Chronic Graft vs Host Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Budesonide

Intervention Description

3 mg TID

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0 mg TID

Primary Outcome Measure Information:

Title

Rate of patients with objective response

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Rate of complete/partial response, stable disease, progressive disease

Time Frame

12 weeks

Title

Time to initial objective response

Time Frame

x weeks

Title

Rate of subjective improvement

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Elad, DMD

Organizational Affiliation

University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Regensburg

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

12627101

Citation

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. doi: 10.1067/moe.2003.23.

Results Reference

background

PubMed Identifier

21703973

Citation

Elad S, Zeevi I, Finke J, Koldehoff M, Schwerdtfeger R, Wolff D, Mohrbacher R, Levitt M, Greinwald R, Shapira MY. Improvement in oral chronic graft-versus-host disease with the administration of effervescent tablets of topical budesonide-an open, randomized, multicenter study. Biol Blood Marrow Transplant. 2012 Jan;18(1):134-40. doi: 10.1016/j.bbmt.2011.06.001. Epub 2011 Jun 12.

Results Reference

derived

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

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