Back to resultsTherapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy (PORTOALEGRE)
Primary Purpose
Hepatic Encephalopathy
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
L-ornithine-L-aspartate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring minimal hepatic encephalopathy, L-ornithine-L-aspartate, psychometric test, critical flicker frequency, quality of life, Treatment, Health-related quality of life
Eligibility Criteria
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
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L-ornithine-L-aspartate
placebo
Arm Description
5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days
5 g (1 sachet) of placebo comparator three times per day for 60 days
Outcomes
Primary Outcome Measures
Psychometric tests and critical flicker frequency
Secondary Outcome Measures
Ammonia concentration
Health-related quality of life
Safety analysis
Full Information
NCT ID
NCT00896831
First Posted
May 11, 2009
Last Updated
June 5, 2009
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00896831
Brief Title
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
minimal hepatic encephalopathy, L-ornithine-L-aspartate, psychometric test, critical flicker frequency, quality of life, Treatment, Health-related quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L-ornithine-L-aspartate
Arm Type
Active Comparator
Arm Description
5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
5 g (1 sachet) of placebo comparator three times per day for 60 days
Intervention Type
Drug
Intervention Name(s)
L-ornithine-L-aspartate
Intervention Description
L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo: 5 g (1 sachet) three times per day for 60 days
Primary Outcome Measure Information:
Title
Psychometric tests and critical flicker frequency
Time Frame
day 0, 15, 30, 45 and 60
Secondary Outcome Measure Information:
Title
Ammonia concentration
Time Frame
time 0 and 60 days after
Title
Health-related quality of life
Time Frame
time 0 and 60 days after
Title
Safety analysis
Time Frame
time 0 and 60 days after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mário R Álvares-da-Silva, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy
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