CClinicalTrials.gg
Sign In
CompletedNCT00887263Updated Jan 21, 2016

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

A Phase 3 interventional study of Budesonide and Placebo in Oral Chronic Graft vs Host Disease, sponsored by Dr. Falk Pharma GmbH. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-21.

Sponsored by Dr. Falk Pharma GmbH · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Oral Chronic Graft vs Host Disease

Browse trials for

03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 186 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    A

    Drug: Budesonide

  • Placebo comparator
    B

    Drug: Placebo

Interventions

  • DrugBudesonide

    3 mg TID

  • DrugPlacebo

    0 mg TID

06

What researchers measure

Primary outcomes

  1. Rate of patients with objective response

    Time frame: 12 weeks

Secondary outcomes

  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

07

Study locations

2 sites
  • University of Regensburg
    Regensburg, 93053, Germany
  • The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine
    Jerusalem, 91120, Israel
08

References and documents

Publications

  • 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. PubMed 12627101 ↗
  • 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. PubMed 21703973 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00887263
Lead sponsor
Dr. Falk Pharma GmbH
Responsible party
Sponsor
First posted
Apr 23, 2009
Start date
Mar 2009
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Jan 21, 2016

Study contacts

Sharon Elad, DMD
principal investigator · University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Graft vs Host Disease→

Other studies from this sponsor

Dr. Falk Pharma GmbH

Start the discussion