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

This study is currently recruiting participants.
Verified March 2014 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00887263
First received: April 22, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Oral Chronic Graft vs Host Disease
Drug: Budesonide
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of patients with objective response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complete/partial response, stable disease, progressive disease [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to initial objective response [ Time Frame: x weeks ] [ Designated as safety issue: No ]
  • Rate of subjective improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Budesonide
3 mg TID
Placebo Comparator: B Drug: Placebo
0 mg TID

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887263

Contacts
Contact: Ralf Mohrbacher, MSc ++49 761 1514-0 ext 156 mohrbacher@drfalkpharma.de
Contact: Daniel Wolff, MD ++49 941 944-0 ext 5531 daniel.wolff@klinik.uni-regensburg.de

Locations
Germany
University of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Daniel Wolff, MD    ++49 941 944-0 ext 5531    daniel.wolff@klinik.uni-regensburg.de   
Principal Investigator: Daniel Wolff, MD         
Israel
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine Recruiting
Jerusalem, Israel, 91120
Contact: Michael Shapira, MD    ++972 2 6777735    SHAPIRAM@hadassah.org.il   
Principal Investigator: Sharon Elad, DMD         
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Sharon Elad, DMD University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT00887263     History of Changes
Other Study ID Numbers: BUM-5/GVH
Study First Received: April 22, 2009
Last Updated: March 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014