Status:
COMPLETED
Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD
Lead Sponsor:
Enteron Pharmaceuticals
Conditions:
Graft Vs Host Disease
Gastrointestinal Graft-Versus-Host Disease
Eligibility:
All Genders
Phase:
PHASE3
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 o...
Detailed Description
Patient selection. Patients who develop symptoms of GVHD are evaluated with endoscopy and mucosal biopsy. If biopsy specimens demonstrate histologic findings of GVHD and stool and mucosal biopsy cultu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00233896
Start Date
July 1 2001
End Date
December 1 2004
Last Update
October 6 2005
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109