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Sponsored by: |
Aga Khan University |
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Information provided by: | Aga Khan University |
ClinicalTrials.gov Identifier: | NCT00433368 |
The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.
Condition | Intervention | Phase |
---|---|---|
Hepatic Encephalopathy |
Drug: L-Ornithine L-Aspartate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of a Three Days’ Infusion of L-Ornithine-L-Aspartate as an Adjuvant Therapy in Cirrhotic Patients With Overt Hepatic Encephalopathy: A Placebo Controlled Study |
Estimated Enrollment: | 108 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | September 2004 |
There is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by which the body rids itself of excess ammonia. Ornithine is a specific activator of ornithine carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for ureagenesis. These reactions are carried out mainly in the periportal portion of the hepatic lobules. Aspartate and ornithine, after conversion to alfa-ketoglutarate, are substrates for glutamine synthesis, which is performed exclusively by a small population of perivenous hepatocytes, the so-called perivenous scavenger cells. The ammonia lowering effect resulting from the stimulation of these two basic mechanisms of ammonia detoxification has been studied in animals and was confirmed in humans in clinical trials.
Ages Eligible for Study: | 14 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pakistan, Sind | |
Aga Khan University Hospital | |
Karachi, Sind, Pakistan, 74800 |
Study Chair: | Wasim Jafri, MD; FRCP | Chairman Department of Medicine, Aga Khan University Hospital |
Principal Investigator: | Shahab Abid, MD | Associate Professor, Department of Medicine, Aga Khan University |
Study ID Numbers: | OA001 |
Study First Received: | February 8, 2007 |
Last Updated: | February 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00433368 History of Changes |
Health Authority: | Pakistan: Research Ethics Committee |
L-ornithine-L-aspartate, porto-systemic encephalopathy, hepatic encephalopathy, liver cirrhosis, mental state |
Neurotransmitter Agents Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Disorders of Environmental Origin Liver Cirrhosis Brain Diseases N-Methylaspartate Signs and Symptoms Mental Disorders Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations Hepatic Insufficiency |
Delirium Excitatory Amino Acids Liver Failure Metabolic Diseases Adjuvants, Immunologic 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 |
Neurotransmitter Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Neurotoxicity Syndromes Excitatory Amino Acid Agonists Physiological Effects of Drugs Brain Damage, Chronic Disorders of Environmental Origin Excitatory Amino Acid Agents Central Nervous System Viral Diseases Brain Diseases N-Methylaspartate Signs and Symptoms Mental Disorders Neurobehavioral Manifestations |
Hepatic Insufficiency Delirium Liver Failure Metabolic Diseases Nervous System Diseases 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 |