Back to resultsRosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Primary Purpose
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
avandia
metformin
losartan
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring nonalcoholic steatohepatitis (NASH), fatty liver, insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Patients between 18-70 years old
- Negative urine pregnancy test in females
- History of elevated liver associated enzymes (ALT > 40)
- Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH
Exclusion Criteria:
- ALT greater than three times normal
- NYHA class 3 or 4 heart failure
- Any congestive heart failure patient on insulin
- Patients on one of the 3 study drugs within the past 3 months prior to enrollment
- Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
- Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
- Serum creatinine on initial screening of greater than 1.4
- Known hypersensitivity to rosiglitazone, metformin, or losartan
- Known history of diabetic ketoacidosis
- Female that is breastfeeding
- Insulin dependent diabetic
Sites / Locations
- Brooke Army Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
avandia
avandia plus metformin
avandia plus losartan
Outcomes
Primary Outcome Measures
liver biopsy histologic improvement
Secondary Outcome Measures
serum transaminases
Full Information
NCT ID
NCT00699036
First Posted
June 16, 2008
Last Updated
June 18, 2009
Sponsor
Brooke Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00699036
Brief Title
Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Official Title
Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Brooke Army Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
Keywords
nonalcoholic steatohepatitis (NASH), fatty liver, insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
avandia
Arm Title
2
Arm Type
Experimental
Arm Description
avandia plus metformin
Arm Title
3
Arm Type
Experimental
Arm Description
avandia plus losartan
Intervention Type
Drug
Intervention Name(s)
avandia
Intervention Description
4 mg twice daily
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
500 mg twice daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
losartan
Intervention Description
losartan 50 mg once daily
Primary Outcome Measure Information:
Title
liver biopsy histologic improvement
Time Frame
end of study
Secondary Outcome Measure Information:
Title
serum transaminases
Time Frame
throughout study (ongoing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 18-70 years old
Negative urine pregnancy test in females
History of elevated liver associated enzymes (ALT > 40)
Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH
Exclusion Criteria:
ALT greater than three times normal
NYHA class 3 or 4 heart failure
Any congestive heart failure patient on insulin
Patients on one of the 3 study drugs within the past 3 months prior to enrollment
Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
Serum creatinine on initial screening of greater than 1.4
Known hypersensitivity to rosiglitazone, metformin, or losartan
Known history of diabetic ketoacidosis
Female that is breastfeeding
Insulin dependent diabetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M Torres, MD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn M Torres, MD
Phone
210-916-5649
First Name & Middle Initial & Last Name & Degree
Dawn M Torres, MD
First Name & Middle Initial & Last Name & Degree
Stephen A Harrison, MD
12. IPD Sharing Statement
Learn more about this trial
Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
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