Hepatic EncephalopathyPhase 4PORTOALEGRENCT00896831
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy
A Phase 4 study testing L-ornithine-L-aspartate in people with Hepatic Encephalopathy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- L-ornithine-L-aspartate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency
Who cannot join
- Hepatic encephalopathy grade 1 to 4
- Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
- Psychoactive substance use within 72 hours
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study
The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.
Read the 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
- Being tested
- L-ornithine-L-aspartate, placebo
- Keywords
- minimal hepatic encephalopathy, L-ornithine-L-aspartate, psychometric test, critical flicker frequency, quality of life, Treatment, Health-related quality of life
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-ornithine-L-aspartateDrug
L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days
placeboDrug
Placebo: 5 g (1 sachet) three times per day for 60 days
| Study group | Role | What they receive |
|---|---|---|
| L-ornithine-L-aspartate | Active comparator | 5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days Receives: Drug: L-ornithine-L-aspartate |
| placebo | Placebo comparator | 5 g (1 sachet) of placebo comparator three times per day for 60 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric tests and critical flicker frequency
Measured: day 0, 15, 30, 45 and 60
Secondary outcomes (3)
Ammonia concentration
Measured: time 0 and 60 days after
Health-related quality of life
Measured: time 0 and 60 days after
Safety analysis
Measured: time 0 and 60 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Mário R Álvares-da-Silva, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896831
- Sponsor's protocol ID
- 08461
- Acronym
- PORTOALEGRE
- Status last verified
- Jun 2009
- First submitted
- 11 May 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study
- ClinicalTrials.gov ID
- NCT00896831
- Acronym / sponsor ID
- PORTOALEGRE / 08461
- Conditions
- Hepatic Encephalopathy
- Keywords
- minimal hepatic encephalopathy, L-ornithine-L-aspartate, psychometric test, critical flicker frequency, quality of life, Treatment, Health-related quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-ornithine-L-aspartate | Active comparator | Drug: L-ornithine-L-aspartate5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days |
| placebo | Placebo comparator | Drug: placebo5 g (1 sachet) of placebo comparator three times per day for 60 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency
Key exclusion criteria (3 listed)
- Hepatic encephalopathy grade 1 to 4
- Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
- Psychoactive substance use within 72 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-ornithine-L-aspartateL-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days | Drug | L-ornithine-L-aspartate |
| placeboPlacebo: 5 g (1 sachet) three times per day for 60 days | Drug | placebo |
Primary outcome
Psychometric tests and critical flicker frequency
Time frame: day 0, 15, 30, 45 and 60
3 secondary outcomes
Ammonia concentration
Time frame: time 0 and 60 days after
Health-related quality of life
Time frame: time 0 and 60 days after
Safety analysis
Time frame: time 0 and 60 days after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mário R Álvares-da-Silva, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-ornithine-L-aspartate in people with Hepatic Encephalopathy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric tests and critical flicker frequency (time frame: day 0, 15, 30, 45 and 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2009.