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

NCT00233896 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2005-10-06

No results posted yet for this study

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.

Conditions

  • Graft Vs Host Disease
  • Gastrointestinal Graft-Versus-Host Disease

Interventions

DRUG

Oral beclomethasone dipropionate (drug)

Sponsors & Collaborators

  • Enteron Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Timothy C. Rodell, M.D. · Enteron Pharmaceuticals, Inc., a subsidiary of DOR BioPharma

  • Scott Cruickshank, Ph.D. · Enteron Pharmaceuticals Inc, a subsidiary of DOR BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Completion
2004-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00233896 on ClinicalTrials.gov