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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 is a Phase 3 study that has completed, run by University of California, Davis. The registered enrollment target is 94 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00573313
The ClinicalTrials.gov registry entry for NCT00573313 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00573313 reports 0 study locations.
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.
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