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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
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Graft Vs Host Disease Gastrointestinal Graft-Versus-Host Disease Drug: Oral beclomethasone dipropionate (drug) Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : December 2004


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Treatment failure (that is, flares of GVHD requiring immunosuppressive drug therapy) at study day 50.

Secondary Outcome Measures :
  1. Treatment failure at study day 80.
  2. Survival at transplant day 200.
  3. Adverse events.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Enteron Pharmaceuticals
Investigators
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
More Information

Publications:
Hockenbery DM, Cruickshank S, Rodell TC, McDonald GB. A phase 3 randomized, placebo-controlled study of oral beclomethasone 17, 21-dipropionate (BDP) in conjunction with ten days of high-dose prednisone therapy for patients with gastrointestinal graft vs. host disease. Proceedings of the American Association for Cancer Research 45 (Supplement): 109, 2005. Presented at the annual meeting of the American Association for Cancer Research, Anaheim, CA, 2005.

ClinicalTrials.gov Identifier: NCT00233896     History of Changes
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

Keywords provided by Enteron Pharmaceuticals:
Hematopoietic cell transplant
Acute graft-vs.-host disease
Gastrointestinal tract
Randomized trial
Topical corticosteroid
Beclomethasone dipropionate
Prednisone
Survival

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisone
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Asthmatic Agents
Respiratory System Agents