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Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Oral Leukoplakia Clinical Trial

Official title:
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Clinical Trial Summary

This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in > 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05727761
Study type Interventional
Source University of Minnesota
Contact Beverly Wuertz
Phone 612-625-3090
Email knier003@umn.edu
Status Not yet recruiting
Phase Phase 2
Start date June 15, 2024
Completion date March 15, 2027
View Details
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