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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014