At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 93 enrolled
Drug / intervention
metformin hydrochloride +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.
Randomized Double Blind Placebo Controlled Trial of Barrett's Esophagus Chemoprevention With Metformin
In Brief
A Phase 2 clinical trial evaluating metformin hydrochloride and placebo for Barrett Esophagus and Esophageal Cancer. Completed, enrolled 93 participants across 7 sites in 3 countries.
Detailed Summary
This randomized phase II trial studies how well metformin hydrochloride works in preventing esophageal cancer in patients with Barrett esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may keep esophageal cancer from forming.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarrett Esophagus, Esophageal Cancer
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartJun 2012
Primary CompletionMay 2013
Study CompletionSep 2013
TodayJul 2026
First PostedOct 6, 2011
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.7 years ago
Interventions
metformin hydrochloridedrug
Given PO QD and BID
placeboother
Given PO QD and BID