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

Overview[ - collapse ][ - ]

Purpose 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?
ConditionNonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver Disease
InterventionDrug: avandia
Drug: metformin
Drug: losartan
PhasePhase 2
SponsorBrooke Army Medical Center
Responsible PartyBrooke Army Medical Center
ClinicalTrials.gov IdentifierNCT00699036
First ReceivedJune 16, 2008
Last UpdatedJune 18, 2009
Last verifiedJune 2009

Tracking Information[ + expand ][ + ]

First Received DateJune 16, 2008
Last Updated DateJune 18, 2009
Start DateApril 2007
Estimated Primary Completion DateAugust 2009
Current Primary Outcome Measuresliver biopsy histologic improvement [Time Frame: end of study] [Designated as safety issue: No]
Current Secondary Outcome Measuresserum transaminases [Time Frame: throughout study (ongoing)] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleRosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Official TitleRosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
Brief Summary
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?
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Nonalcoholic Steatohepatitis
  • Nonalcoholic Fatty Liver Disease
InterventionDrug: avandia
4 mg twice daily
Drug: metformin
500 mg twice daily for 48 weeks
Drug: losartan
losartan 50 mg once daily
Study Arm (s)
  • Experimental: 1
    avandia
  • Experimental: 2
    avandia plus metformin
  • Experimental: 3
    avandia plus losartan

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment165
Estimated Completion DateAugust 2009
Estimated Primary Completion DateJuly 2009
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00699036
Other Study ID NumbersC.2007.066
Has Data Monitoring CommitteeYes
Information Provided ByBrooke Army Medical Center
Study SponsorBrooke Army Medical Center
CollaboratorsNot Provided
Investigators Principal Investigator: Dawn M Torres, MD Brooke Army Medical Center
Verification DateJune 2009

Locations[ + expand ][ + ]

Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Contact: Dawn M Torres, MD | 210-916-5649
Principal Investigator: Dawn M Torres, MD
Recruiting