Hepatic EncephalopathyPhase 4NCT00740142
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
A Phase 4 study testing L-ornithine-L-aspartate and lactulose in people with Hepatic Encephalopathy, run by Mahidol University at 1 site in Thailand.
Trial summary
Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- L-ornithine-L-aspartate and lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2008to Oct 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis
- Age 18-80
- Hepatic encephalopathy grade II-III
- Serum ammonia > 60 mcg/mL
- Informed consent
Who cannot join
- Recent GI hemorrhage
- Severe sepsis
- Degenerative CNS disease or major psychiatric illness
- Serum creatinine > 1.5 mg/dl
- Pregnancy or lactation
- Poorly controlled DM
Show all 10Show fewer
- Insertion of TIPS
- Received CNS depressants or hypnotics
- Treatment with metronidazole, kanamycin or branched-chain amino acid
- Hypersensitivity to L-ornithine-L-aspartate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy
Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial
Read the detailed description
Data collection
- Baseline characteristics
- demographic data; age, gender, BW, height
- cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
- comorbidity such as DM, CVA
- After randomization
- assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
- blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
- record adverse effect of drug such as nausea, vomiting, bloating.
- record diet, frequency of bowel movement and stool pH
- compliance
- Conditions
- Hepatic Encephalopathy
- Being tested
- L-ornithine-L-aspartate and lactulose, placebo and lactulose
- Keywords
- L ornithine L aspartate, Lactulose, Hepatic encephalopathy, LOLA
- 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-aspartate and lactuloseDrug
L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
placebo and lactuloseDrug
placebo 3 times a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Interventional arm: oral L-ornithine-L-aspartate and oral lactulose Receives: Drug: L-ornithine-L-aspartate and lactulose |
| 2 | Placebo comparator | Oral lactulose Receives: Drug: placebo and lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess improvement of mental status of the patients
Measured: 7 days
Secondary outcomes (1)
To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionOct 2011
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 Mahidol UniversityThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siwaporn Chainuvati, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740142
- Sponsor's protocol ID
- Si 341/2008
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2008
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT00740142
- Acronym / sponsor ID
- Si 341/2008
- Conditions
- Hepatic Encephalopathy
- Keywords
- L ornithine L aspartate, Lactulose, Hepatic encephalopathy, LOLA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Aug 2008 (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.
Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial
Detailed description
Data collection
- Baseline characteristics
- demographic data; age, gender, BW, height
- cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
- comorbidity such as DM, CVA
- After randomization
- assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
- blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
- record adverse effect of drug such as nausea, vomiting, bloating.
- record diet, frequency of bowel movement and stool pH
- compliance
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 |
|---|---|---|
| 1 | Active comparator | Drug: L-ornithine-L-aspartate and lactuloseInterventional arm: oral L-ornithine-L-aspartate and oral lactulose |
| 2 | Placebo comparator | Drug: placebo and lactuloseOral lactulose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cirrhosis
- Age 18-80
- Hepatic encephalopathy grade II-III
- Serum ammonia > 60 mcg/mL
- Informed consent
Key exclusion criteria (10 listed)
- Recent GI hemorrhage
- Severe sepsis
- Degenerative CNS disease or major psychiatric illness
- Serum creatinine > 1.5 mg/dl
- Pregnancy or lactation
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-aspartate and lactuloseL-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days | Drug | 1 |
| placebo and lactuloseplacebo 3 times a day for 7 days | Drug | 2 |
Primary outcome
To assess improvement of mental status of the patients
Time frame: 7 days
1 secondary outcome
To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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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.
Siwaporn Chainuvati, MD principal investigator
Mahidol University
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 and lactulose in people with Hepatic Encephalopathy, run by Mahidol University at 1 site in Thailand.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 4 Sep 2020. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess improvement of mental status of the patients (time frame: 7 days). 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 4 Sep 2020.