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Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy (PORTOALEGRE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00896831
First received: May 11, 2009
Last updated: June 5, 2009
Last verified: June 2009
History of Changes
  Purpose

The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.


Condition Intervention Phase
Hepatic Encephalopathy
 Drug: L-ornithine-L-aspartate
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Psychometric tests and critical flicker frequency [ Time Frame: day 0, 15, 30, 45 and 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ammonia concentration [ Time Frame: time 0 and 60 days after ] [ Designated as safety issue: Yes ]
  • Health-related quality of life [ Time Frame: time 0 and 60 days after ] [ Designated as safety issue: Yes ]
  • Safety analysis [ Time Frame: time 0 and 60 days after ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: November 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-ornithine-L-aspartate
5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days
 Drug: L-ornithine-L-aspartate
L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days
Placebo Comparator: placebo
5 g (1 sachet) of placebo comparator three times per day for 60 days
 Drug: placebo
Placebo: 5 g (1 sachet) three times per day for 60 days

Detailed Description:

Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency

Exclusion Criteria:

  • Hepatic encephalopathy grade 1 to 4
  • Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
  • Psychoactive substance use within 72 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896831

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Mário R Álvares-da-Silva, PhD Hospital de Clínicas de Porto Alegre
  More Information

No publications provided

Responsible Party: Mário Reis Álvares-da-Silva, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00896831     History of Changes
Other Study ID Numbers: 08461
Study First Received: May 11, 2009
Last Updated: June 5, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
minimal hepatic encephalopathy
L-ornithine-L-aspartate
psychometric test
critical flicker frequency
 quality of life
Treatment
Health-related quality of life

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion
 Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013