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

This study is currently recruiting participants.
Verified February 2013 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: February 12, 2013
Last verified: February 2013
History of Changes

April 22, 2009
February 12, 2013
March 2009
December 2014   (final data collection date for primary outcome measure)
Rate of patients with objective response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887263 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Oral Chronic Graft vs Host Disease
  • Drug: Budesonide
    3 mg TID
  • Drug: Placebo
    0 mg TID
  • Experimental: A
    Intervention: Drug: Budesonide
  • Placebo Comparator: B
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
225
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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
Germany,   Israel
 
NCT00887263
BUM-5/GVH
Yes
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Sharon Elad, DMD University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health
Dr. Falk Pharma GmbH
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP