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Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)

NCT00227110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2009-10-14

No results posted yet for this study

Summary

To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).

Conditions

Interventions

DRUG

Pioglitazone

30 mg/d for 8 weeks and titrated to 45 mg/d until completing 6 months of treatment.

DRUG

Placebo

Placebo is given to match pioglitazone.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Takeda Pharmaceuticals North America, Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Kenneth Cusi, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2005-11-30
Completion
2006-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00227110 on ClinicalTrials.gov