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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896831
First Posted: May 12, 2009
Last Update Posted: June 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 11, 2009
First Posted: May 12, 2009
Last Update Posted: June 10, 2009
Last Verified: June 2009

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:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs