| Trial ID: | L0215 |
| Source ID: | NCT00586911
|
| Associated Drug: |
Betaine
|
| Title: |
Betaine in Patients With Nonalcoholic Steatohepatitis
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Cystadane|Drug: Identical Placebo
|
| Outcome Measures: |
changes in degree of steatosis, necroinflammatory activity and fibrosis in liver biopsy.|Secondary end-points will be changes in liver test results and health related quality of life.
|
| Sponsor/Collaborators: |
Mayo Clinic|University of Florida|Orphan Medical
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
26
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
January 2003
|
| Completion Date: |
June 2006
|
| Results First Posted: |
--
|
| Last Update Posted: |
April 8, 2015
|
| Locations: |
University of Florida at Gainesville, Gainesville, Florida, United States|Mayo Clinic, Rochester, Minnesota, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00586911
|
