NCT01097304

Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

Clinical Study of Ursodeoxycholic Acid in Barrett's Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or cells that look abnormal under a microscope but are not cancer (low-grade dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade dysplasia.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the ability of UDCA (ursodiol) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus. SECONDARY OBJECTIVES: I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium. OUTLINE: Patients receive ursodiol orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up for 2 weeks.

Conditions

• Barrett Esophagus
• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Ursodiol	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-04-01
• Completion: 2014-07-01
• First posted: 2010-04-01
• Last updated: 2017-12-19
• Results posted: 2015-05-15

Locations

4 sites across 1 country: United States