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Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

NCT01447927 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2014-07-21

Study results available
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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.

Conditions

  • Barrett Esophagus
  • Esophageal Cancer

Interventions

DRUG

metformin hydrochloride

Given PO QD and BID

OTHER

placebo

Given PO QD and BID

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Amitabh Chak · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-05-31
Completion
2013-09-30

Countries

  • United States
  • Canada
  • Puerto Rico

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 NCT01447927 on ClinicalTrials.gov