At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
Ursodiol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study of Ursodeoxycholic Acid in Barrett's Patients
In Brief
A Phase 2 clinical trial evaluating Ursodiol and Laboratory Biomarker Analysis for Barrett Esophagus and Esophageal Carcinoma. Completed, enrolled 36 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarrett Esophagus, Esophageal Carcinoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartApr 2010
Primary CompletionApr 2014
Study CompletionJul 2014
TodayJul 2026
First PostedApr 1, 2010
Enrollment StartApr 1, 2010
Primary CompletionApr 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.3 years ago
Interventions
Ursodioldrug
Given PO
Laboratory Biomarker Analysisother
Correlative studies