Phase IIB Randomized, Placebo Controlled Trial of Pioglitazone for Oral Premalignant Lesions: An Inter-Consortium Collaborative Study

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Title Phase IIB Randomized, Placebo Controlled Trial of Pioglitazone for Oral Premalignant Lesions: An Inter-Consortium Collaborative Study
Contact DN
Principal Investigator Maureen Sullivan, DDS
Study Number 162709
Phase2
Summary This is a Phase IIb trial which will study the effectiveness of pioglitazone as therapy for pre-cancerous lesions of the mouth.
Eligibility
  • 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
For more information about the clinical study go to Clinicaltrial.Gov