CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 94 enrolled
Drug / intervention
S-adenosylmethionine +1 moredrug
Likely dose
S-adenosylmethionine 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00573313
NCT00573313Phase 3Completed
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Effects of SAMe in Patients With Alcoholic Liver Disease

University of California, Davis·interventional·Posted Dec 14, 2007·Updated May 30, 2017

In Brief

A Phase 3 clinical trial evaluating S-adenosylmethionine and Placebo for Liver Disease, Alcoholic. Completed, enrolled 94 participants across 1 site.

Detailed Summary

Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Disease, Alcoholic
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA), Abbott, Joint Clinical Research Center, University of Colorado, Denver, University of California, Los Angeles

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2007
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.6 years ago

Interventions

S-adenosylmethioninedrug

Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.

Placebodrug

Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.