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

June 5, 2009 updated by: Hospital de Clinicas de Porto Alegre

Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychometric tests and critical flicker frequency
Time Frame: day 0, 15, 30, 45 and 60
day 0, 15, 30, 45 and 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Ammonia concentration
Time Frame: time 0 and 60 days after
time 0 and 60 days after
Health-related quality of life
Time Frame: time 0 and 60 days after
time 0 and 60 days after
Safety analysis
Time Frame: time 0 and 60 days after
time 0 and 60 days after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Mário R Álvares-da-Silva, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2009

Last Update Submitted That Met QC Criteria

June 5, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08461

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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