Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00233896|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : October 6, 2005
|Condition or disease||Intervention/treatment||Phase|
|Graft Vs Host Disease Gastrointestinal Graft-Versus-Host Disease||Drug: Oral beclomethasone dipropionate (drug)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Placebo-Controlled, Multi-Center Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal Graft Vs. Host Disease|
|Study Start Date :||July 2001|
|Study Completion Date :||December 2004|
- Treatment failure (that is, flares of GVHD requiring immunosuppressive drug therapy) at study day 50.
- Treatment failure at study day 80.
- Survival at transplant day 200.
- Adverse events.
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): NCT00233896
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Director:||Timothy C. Rodell, M.D.||Enteron Pharmaceuticals, Inc., a subsidiary of DOR BioPharma|
|Study Director:||Scott Cruickshank, Ph.D.||Enteron Pharmaceuticals Inc, a subsidiary of DOR BioPharma|