NCT00896831

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	L-ornithine-L-aspartate	L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days
DRUG	placebo	Placebo: 5 g (1 sachet) three times per day for 60 days

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-03-01
• Completion: 2010-09-01
• First posted: 2009-05-12
• Last updated: 2009-06-10

Locations

1 site across 1 country: Brazil