Title Phase IIB Randomized, Placebo Controlled Trial of Pioglitazone for Oral Premalignant Lesions: An Inter-Consortium Collaborative Study
Principal Investigator Maureen Sullivan, DDS
Study Number 162709
Summary This is a Phase IIb trial which will study the effectiveness of pioglitazone as therapy for pre-cancerous lesions of the mouth.
- Males or females with a suspected or histologically confirmed oral premalignant lesion(s) [*up to three target lesions may be followed for the purpose of the study] that has a length (longest diameter) of 8mm or greater and width (diameter perpendicular to greatest length) of 3mm or greater in size.
- Greater than or equal to 18 years of age
- A life expectancy of greater than 6 months
- Female candidates are not pregnant or lactating
- Candidates do not have congestive heart failure, uncontrolled hypertension or unstable angina
- Candidates do not have known diabetes, or are taking insulin or oral agents to control blood sugars