NCT00887263

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

6.6 years

First QC Date

April 22, 2009

Last Update Submit

January 20, 2016

Conditions

Oral Chronic Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with objective response

    12 weeks

Secondary Outcomes (3)

  • Rate of complete/partial response, stable disease, progressive disease

    12 weeks

  • Time to initial objective response

    x weeks

  • Rate of subjective improvement

    12 weeks

Study Arms (2)

A

EXPERIMENTAL
Drug: Budesonide

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BudesonideDRUG

3 mg TID

A
PlaceboDRUG

0 mg TID

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Regensburg

Regensburg, 93053, Germany

Location

The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine

Jerusalem, 91120, Israel

Location

Related Publications (2)

  • 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.

    PMID: 12627101BACKGROUND

  • 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.

    PMID: 21703973DERIVED

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Sharon Elad, DMD

    University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

DE(1)IL(1)