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

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: L-ornithine-L-aspartate; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00896831

08461

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

L-ornithine-L-aspartate

Active Comparator group

Description:

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

Treatment:

Drug: L-ornithine-L-aspartate

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo