Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD

This study has been completed.
Sponsor:
Information provided by:
Enteron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00233896
First received: October 4, 2005
Last updated: NA
Last verified: December 2004
History: No changes posted
  Purpose

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
Graft Vs Host Disease
Gastrointestinal Graft-Versus-Host Disease
Drug: Oral beclomethasone dipropionate (drug)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Enteron Pharmaceuticals:

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

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

Estimated Enrollment: 130
Study Start Date: July 2001
Estimated Study Completion Date: December 2004
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
ClinicalTrials.gov Identifier: NCT00233896     History of Changes
Other Study ID Numbers: ENT 00-02
Study First Received: October 4, 2005
Last Updated: October 4, 2005
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014