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Sponsored by: |
Enteron Pharmaceuticals |
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Information provided by: | Enteron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00233896 |
Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under control undergo a rapid prednisone taper over 7 days, while study drug is continued to study day 50. After discontinuation of study drug at study day 50, patients are followed for 30 additional days, to study day 80. The primary endpoint is treatment failure by day 50, that is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while maintaining control of intestinal GVHD.
Condition | Intervention | Phase |
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Graft Vs Host Disease Gastrointestinal Graft-Versus-Host Disease |
Drug: Oral beclomethasone dipropionate (drug) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 130 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | December 2004 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | ENT 00-02 |
Study First Received: | October 4, 2005 |
Last Updated: | October 4, 2005 |
ClinicalTrials.gov Identifier: | NCT00233896 |
Health Authority: | United States: Food and Drug Administration |
Hematopoietic cell transplant Acute graft-vs.-host disease Gastrointestinal tract Randomized trial |
Topical corticosteroid Beclomethasone dipropionate Prednisone Survival |
Prednisone Graft versus host disease Beclomethasone Graft vs Host Disease Homologous wasting disease |
Anti-Inflammatory Agents Respiratory System Agents Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Hormones Glucocorticoids Pharmacologic Actions |