Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD
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ClinicalTrials.gov Identifier: NCT00233896 |
Recruitment Status :
Completed
First Posted : October 6, 2005
Last Update Posted : October 6, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft Vs Host Disease Gastrointestinal Graft-Versus-Host Disease | Drug: Oral beclomethasone dipropionate (drug) | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Allogeneic hematopoietic cell transplant ≥10 days prior to screening
- Symptoms consistent with Grade II intestinal GVHD
- Diagnosis of GVHD confirmed by biopsy
- Confirmed absence of intestinal infection
- Demonstrated ability to swallow 2 tablets of the size and configuration of study drug
- Anti-candidal prophylaxis of the oropharynx
- If female and of childbearing potential, willing to use contraception
- Ability to read, understand, and sign informed consent
Exclusion Criteria:
- Skin GVHD other than a slowly evolving skin rash that involves ≤50% of body surface
- Liver GVHD with total serum bilirubin >3 mg/dL
- Negative intestinal biopsy for GVHD
- Systemic prescription corticosteroid use within 30 days
- Persistent vomiting of oral intake the precludes ingestion of study drug tablets
- Multiorgan failure
- Infection of the mouth or esophagus with a fungal organism
- Known HIV seropositivity
- Pregnancy or lactation
- Previous use of BDP tablets, capsules, or inhalation products
- Use of any investigational drug, biologic, or device within 30 days
- Inability to comply with study procedures and scheduled study visits

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 |
Other Publications:
ClinicalTrials.gov Identifier: | NCT00233896 |
Other Study ID Numbers: |
ENT 00-02 |
First Posted: | October 6, 2005 Key Record Dates |
Last Update Posted: | October 6, 2005 |
Last Verified: | December 2004 |
Hematopoietic cell transplant Acute graft-vs.-host disease Gastrointestinal tract Randomized trial |
Topical corticosteroid Beclomethasone dipropionate Prednisone Survival |
Graft vs Host Disease Immune System Diseases Beclomethasone Anti-Inflammatory Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |