Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy

NCT ID: NCT00896831

Last Updated: 2009-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L-ornithine-L-aspartate

5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days

Group Type ACTIVE_COMPARATOR

L-ornithine-L-aspartate

Intervention Type DRUG

L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days

placebo

5 g (1 sachet) of placebo comparator three times per day for 60 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo: 5 g (1 sachet) three times per day for 60 days

Interventions

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L-ornithine-L-aspartate

L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days

Intervention Type DRUG

placebo

Placebo: 5 g (1 sachet) three times per day for 60 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clínicas de Porto Alegre

Principal Investigators

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Mário R Álvares-da-Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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08461

Identifier Type: -

Identifier Source: org_study_id

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