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Sponsored by: |
Salix Pharmaceuticals |
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Information provided by: | Salix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00298038 |
The purpose of this study is to determine if the study drug is safe and effective in preventing Hepatic Encephalopathy (HE).
Condition | Intervention | Phase |
---|---|---|
Hepatic Encephalopathy |
Drug: Rifaximin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy |
Estimated Enrollment: | 250 |
Study Start Date: | December 2005 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
placebo: Placebo Comparator |
Drug: Rifaximin
550 mg tablets BID
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
GI Specialists of Clarksville, PC | |
Clarksville, Tennessee, United States, 37043 |
Study Director: | William Forbes, Pharm D | Salix Pharmaceuticals, Inc. |
Responsible Party: | Salix ( Audrey Shaw, Director Clinical ) |
Study ID Numbers: | RFHE3001 |
Study First Received: | February 28, 2006 |
Last Updated: | October 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00298038 |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Signs and Symptoms Mental Disorders Brain Injuries Dementia Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure Metabolic Diseases Neurotoxicity syndromes |
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 Metabolic disorder Brain Diseases, Metabolic |
Anti-Infective Agents Therapeutic Uses Nervous System Diseases |
Gastrointestinal Agents Central Nervous System Viral Diseases Pharmacologic Actions |