The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Condition	Treatment or Intervention	Phase
Liver Diseases	Drug: Pioglitazone  Drug: Vitamin E  Drug: Placebo	Phase III

Further Study Details: 

Primary Outcomes: Improvement in NASH activity defined by change in standardized scoring of liver biopsies at baseline and after 96 weeks of treatment.
Expected Total Enrollment:  240

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
• Age 18 years or older

California
      University of California, San Diego, San Diego,  California,  92103,  United States; Recruiting
      University of California, San Francisco, San Francisco,  California,  94143,  United States; Recruiting
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States; Recruiting
Missouri
      St. Louis University, St. Louis,  Missouri,  63110,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44109,  United States; Recruiting
Virginia
      Virginia Commonwealth University, Richmond,  Virginia,  23298,  United States; Recruiting
Washington
      University of Washington, Seattle,  Washington,  98195,  United States; Recruiting

Study ID Numbers:  NASH - ADULT
Record last reviewed:  March 2005
Last Updated:  March 16, 2005
Record first received:  July 1, 2003
ClinicalTrials.gov Identifier:  NCT00063622
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08