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NCT00896831 Clinical Trial

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

Hepatic Encephalopathy Clinical Trial

— PORTOALEGRE  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00896831
Other study ID # 08461
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received May 11, 2009
Last updated June 5, 2009
Start date November 2008
Est. completion date September 2010

Study information
Verified date June 2009
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 96
Est. completion date September 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Psychometric tests and critical flicker frequency day 0, 15, 30, 45 and 60 No
Secondary Ammonia concentration time 0 and 60 days after Yes
Secondary Health-related quality of life time 0 and 60 days after Yes
Secondary Safety analysis time 0 and 60 days after Yes
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Completed NCT00740142 - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy Phase 4
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Completed NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group Phase 1
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Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A