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

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ClinicalTrials.gov Identifier: NCT00887263
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Oral Chronic Graft vs Host Disease Drug: Budesonide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: A Drug: Budesonide
3 mg TID
Placebo Comparator: B Drug: Placebo
0 mg TID



Primary Outcome Measures :
  1. Rate of patients with objective response [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Rate of complete/partial response, stable disease, progressive disease [ Time Frame: 12 weeks ]
  2. Time to initial objective response [ Time Frame: x weeks ]
  3. Rate of subjective improvement [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887263


Locations
Germany
University of Regensburg
Regensburg, Germany, 93053
Israel
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine
Jerusalem, Israel, 91120
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

Publications:
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
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
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