Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
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|ClinicalTrials.gov Identifier: NCT00941642|
Recruitment Status : Unknown
Verified June 2010 by Huntington Medical Research Institutes.
Recruitment status was: Recruiting
First Posted : July 17, 2009
Last Update Posted : June 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease||Drug: Lovaza Drug: placebo control||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
U.S. FDA Resources
Active Comparator: Lovaza
Single blind, active treatment arm Lovaza, is the only fish oil supplement approved by the FDA. The Lovaza treatment group will take 4g of Lovaza daily for a minimum of 48 weeks.
Approximately 50% of study subjects will be randomized to the active treatment arm -Lovaza. Subjects will be dosed with 4g of Lovaza gel capsules daily for a minimum of 48 weeks duration.
Placebo Comparator: Placebo
Single blind, Placebo arm study drug will contain 994.0 mg of corn oil and 6mg of alpha tocopherol as an excipient in a soft gelatin capsule shell. Subjects will take 4g daily for a minimum of 48 weeks.
Drug: placebo control
Approximately 50% of study subjects will be randomized to the placebo arm of this study. Placebo arm subjects will receive 4g of placebo gel caps daily for a minimum of 48 weeks duration.
- To determine if Lovaza improves fibrosis and the NASH activity index. [ Time Frame: 48 weeks ]
- To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy. [ Time Frame: 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941642
|Contact: Roberta A Fitzgerald, RNemail@example.com|
|United States, California|
|HMRI - Liver Center||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Roberta A Fitzgerald, RN 626-397-5825 firstname.lastname@example.org|
|Principal Investigator: Edward A Mena, MD|
|Sub-Investigator: Myron J Tong, PhD, MD.|
|Principal Investigator:||Edward A Mena, MD||Huntington Medical Research Institutes - Liver Center|
|Study Director:||Myron J Tong, PhD, MD.||Huntington Medical Research Institutes - Liver Center|