CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 108 enrolled
Drug / intervention
SAMe 1000 mg +2 moredrug
Likely dose
SAMe 1000 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/NCT01754714
NCT01754714Phase 3Completed
CompareCT.gov

Open-label, Randomized, Parallel-Group, Exploratory Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Non-treated Matched Healthy Volunteers as Control Group

Abbott·interventional·Posted Dec 21, 2012·Updated Feb 19, 2016

In Brief

A Phase 3 clinical trial evaluating SAMe 1000 mg, SAMe 1500 mg, and 1 other intervention for Non Alcoholic Fatty Liver Disease. Completed, enrolled 108 participants across 32 sites in 4 countries.

Detailed Summary

Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Alcoholic Fatty Liver Disease
CountriesFrance, Germany, Poland, Russia
CollaboratorsPPD Development, LP

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2012
Enrollment StartDec 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.5 years ago

Interventions

SAMe 1000 mgdrug

1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner

SAMe 1500 mgdrug

1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner

SAMe 2000 mgdrug

2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner