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Sponsors and Collaborators: |
Hunter Holmes Mcguire Veteran Affairs Medical Center Salix Pharmaceuticals |
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Information provided by: | Hunter Holmes Mcguire Veteran Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00533910 |
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.
Condition | Intervention |
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Hepatic Encephalopathy |
Drug: Rifaximin Drug: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Rifaximin on Driving Performance, Psychometric Test Performance and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy: Randomized, Double-Blind, Placebo-Controlled Trial. |
Estimated Enrollment: | 50 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Will be given placebo and follow the exact procedures as the experimental section
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Drug: placebo
same as the experimental arm
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Drug: Experimental |
Drug: Rifaximin
550mg BID rifaximin for 8 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Excluding patients with OHE:
Contact: Jasmohan S Bajaj, MBBS, MD, MS | 804 675 5802 | jasmohan.bajaj@va.gov |
Contact: Kia Saeian, MD, MS | 414-456 -6835 | ksaeian@mcw.edu |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | Recruiting |
Richmond, Virginia, United States, 23249 | |
Principal Investigator: Jasmohan S Bajaj, MBBS, MD, MS |
Principal Investigator: | Jasmohan S Bajaj, MBBS, MD, MS | Medical College of Wisconsin |
Responsible Party: | Hunter Holmes Mcguire Veteran Affairs Medical Center ( Jasmohan Bajaj ) |
Study ID Numbers: | PRO00006863 |
Study First Received: | September 20, 2007 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00533910 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Minimal hepatic encephalopathy |
Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Quality of Life Disorders of Environmental Origin Brain Diseases Signs and Symptoms Mental Disorders Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure |
Metabolic Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Rifaximin Brain Diseases, Metabolic |
Anti-Infective Agents Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Brain Diseases Signs and Symptoms Mental Disorders Therapeutic Uses Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure Metabolic Diseases |
Nervous System Diseases Gastrointestinal Agents Poisoning Central Nervous System Diseases Confusion Pharmacologic Actions Encephalitis Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Rifaximin Brain Diseases, Metabolic |