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Pioglitazone for Oral Premalignant Lesions

NCT00951379 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-04-06

Study results available
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Summary

The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied.

Conditions

  • Oral Leukoplakia

Interventions

DRUG

Pioglitazone hydrochloride

Three (3) pioglitazone 15 mg capsules by mouth once daily for 24 weeks (+/- 1 week)

OTHER

placebo

Three (3) pioglitazone placebo capsules by mouth once daily for 24 weeks (+/- 1 week)

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Powel H. Brown · University of Texas MD Anderson Cancer Center, Consortium PI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Canada
  • Italy

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 NCT00951379 on ClinicalTrials.gov