CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
metformin hydrochloridedrug
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.

Search/NCT01312467
NCT01312467Phase 2Completed

A Phase IIa Trial of Metformin for Colorectal Cancer Risk Reduction Among Patients With a History of Colorectal Adenomas and Elevated Body Mass Index

National Cancer Institute (NCI)·interventional·Posted Mar 10, 2011·Updated Mar 5, 2019

In Brief

A Phase 2 clinical trial evaluating metformin hydrochloride for Adenomatous Polyp and 2 related conditions. Completed, enrolled 45 participants across 4 sites in 2 countries.

Detailed Summary

The purpose of this study is to find out whether METFORMIN decreases protein markers in colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and tolerability of Metformin in decreasing colorectal mucosa in patients with a history of colorectal adenomas in the past 3 years and a BMI \>= 30, with decimals rounded to the nearest whole integer. Metformin as a potential chemopreventive agent for inhibition of the relevant molecular pathways involved in human colorectal carcinogenesis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 10, 2011
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.3 years ago

Interventions

metformin hydrochloridedrug