Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

June 18, 2009 updated by: Brooke Army Medical Center

Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78234
        • Recruiting
        • Brooke Army Medical Center
        • Contact:
          • Dawn M Torres, MD
          • Phone Number: 210-916-5649
        • Principal Investigator:
          • Dawn M Torres, MD
        • Sub-Investigator:
          • Stephen A Harrison, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients between 18-70 years old
  2. Negative urine pregnancy test in females
  3. History of elevated liver associated enzymes (ALT > 40)
  4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria:

  1. ALT greater than three times normal
  2. NYHA class 3 or 4 heart failure
  3. Any congestive heart failure patient on insulin
  4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment
  5. Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
  6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
  7. Serum creatinine on initial screening of greater than 1.4
  8. Known hypersensitivity to rosiglitazone, metformin, or losartan
  9. Known history of diabetic ketoacidosis
  10. Female that is breastfeeding
  11. Insulin dependent diabetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
avandia
Drug: avandia
4 mg twice daily
EXPERIMENTAL: 2
avandia plus metformin
Drug: avandia
4 mg twice daily
Drug: metformin
500 mg twice daily for 48 weeks
EXPERIMENTAL: 3
avandia plus losartan
Drug: avandia
4 mg twice daily
Drug: losartan
losartan 50 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
liver biopsy histologic improvement
Time Frame: end of study
end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
serum transaminases
Time Frame: throughout study (ongoing)
throughout study (ongoing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Dawn M Torres, MD, Brooke Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ANTICIPATED)

July 1, 2009

Study Completion (ANTICIPATED)

August 1, 2009

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (ESTIMATE)

June 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 18, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2007.066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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