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Sponsors and Collaborators: |
Mayo Clinic University of Florida Orphan Medical |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00586911 |
To assess the safety and efficacy of betaine in patients with NASH on markers of disease severity such as liver histology, liver biochemistries, and health related quality of life.
Condition | Intervention | Phase |
---|---|---|
Nonalcoholic Steatohepatitis |
Drug: Cystadane Drug: Identical Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Trial of Betaine in Patients With Nonalcoholic Steatohepatitis (NASH) |
Enrollment: | 26 |
Study Start Date: | January 2003 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Florida at Gainesville | |
Gainesville, Florida, United States, 32610 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Keith D Lindor, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Dr. Keith D. Lindor, MD / PI ) |
Study ID Numbers: | 458-00 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00586911 |
Health Authority: | United States: Food and Drug Administration |
Nonalcoholic Steatohepatitis NASH Betaine |
Liver Diseases Non-alcoholic steatohepatitis (NASH) Digestive System Diseases Fatty Liver Betaine |
Antimetabolites Lipotropic Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |