Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

February 12, 2007

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00180089 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

safety
grade of acute GI GVHD
incidence of chronic GI GVHD
incidence of infectious complications
overall and disease-free survival 1 yr after transplant

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

Official Title ^ICMJE

Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-Versus-Host Disease Following Allogenic Stem Cell Transplantation

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Leukemia
Graft-Versus-Host Disease

Intervention ^ICMJE

Drug: Budesonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

242

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

planned allogenic stem cell or bone marrow transplantation
HLA identity (max. 1 mismatch)
standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
written informed consent

Exclusion Criteria:

history of allogenic transplantation
in vitro T-cell depleted transplant
pretreatment with budesonide within the previous 4 weeks
known intolerance to budesonide
gastrointestinal infections
portal hypertension
concomitant infectious diseases
liver cirrhosis, impaired liver function
severe mental disorder
lack of compliance
drug or alcohol abuse
pregnancy, lactation
childbearing potential without effective contraception

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stephan Miehlke, Prof.	+49 351 458 ext 5645	stephan.miehlke@uniklinikum-dresden.de
Contact: Martin Bornhäuser, Prof.	+49 351 458 ext 4190	martin.bornhaeuser@uniklinikum-dresden.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00180089

Responsible Party

Study ID Numbers ^ICMJE

PROGAST

Study Sponsor ^ICMJE

Dresden University of Technology

Collaborators ^ICMJE

Dr. Falk Pharma GmbH

Investigators ^ICMJE

Principal Investigator:

Stephan Miehlke, Prof.

Medical Department I, Technical University Hospital, Dresden, Germany

Information Provided By

Dresden University of Technology

Verification Date

June 2005

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