NCT01754714

Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Conditions

• Non Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	SAMe 1000 mg	1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
DRUG	SAMe 1500 mg	1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
DRUG	SAMe 2000 mg	2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-12-21
• Last updated: 2016-02-19
• Results posted: 2016-02-19

Locations

32 sites across 4 countries: France, Germany, Poland, Russia