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NCT00573313 · ClinicalTrials.gov registry record · Phase 3
Effects of SAMe in Patients With Alcoholic Liver Disease
A Phase 3 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
NCT00573313: Completed Phase 3 study, sponsored by University of California, Davis.
NCT00573313 is a Phase 3 study that has completed, run by University of California, Davis. The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00573313, a Phase 3 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
Study 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.
Primary Outcome
Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.
Interventions
- DRUG Placebo
- DRUG S-adenosylmethionine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00573313 record still lists
NCT00573313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00573313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00573313 about?
NCT00573313 is a clinical study titled "Effects of SAMe in Patients With Alcoholic Liver Disease". 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-adenosylmethion...
What is the current status of trial NCT00573313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2005-09. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00573313?
The interventions under investigation include: Placebo (DRUG), S-adenosylmethionine (DRUG).
Who is sponsoring clinical trial NCT00573313?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00573313's enrollment target sits among peer trials
94 1719th of 2000 higher than 279 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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