S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis - Tabular View

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S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

This study has been completed.

Study NCT00108589. Last updated on May 15, 2007. Information provided by Department of Veterans Affairs

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Official Title ^†	S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Brief Summary	The purpose of this study is to examine the effect of S-adenosylmethionine therapy in those patients with non-alcoholic liver disease in the form of steatohepatitis (NASH). This will be accomplished by development of a database of these patients, all of whom will have biopsy documented NASH. A placebo controlled trial will then examine the effect of S-adenosylmethionine over time on clinical outcome in these patients. It is expected that this agent will slow or halt the progression of this disease.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Hepatitis
Intervention ^†	Drug: S-adenosylmethionine
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†	January 2004
Completion Date	December 2006
Eligibility Criteria ^†	Inclusion Criteria: Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00108589
Organization ID	CLIN-014-03S
Secondary IDs ^††
Study Sponsor ^†	Department of Veterans Affairs
Collaborators ^††
Investigators ^†
Information Provided By	Department of Veterans Affairs
Verification Date	May 2007
First Received Date ^†	April 15, 2005
Last Updated Date	May 15, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.