Hepatic EncephalopathyPhase 4NCT02158182
Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
A Phase 4 study testing Lactulose, L-ornithine L-aspartate and Rifaximin in people with Hepatic Encephalopathy, run by Hospital General de Mexico at 1 site in Mexico.
Trial summary
The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Lactulose, L-ornithine L-aspartate and Rifaximin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2014to Jun 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria
Who cannot join
- Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients
The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding
- Conditions
- Hepatic Encephalopathy
- Being tested
- Lactulose, L-ornithine L-aspartate, Rifaximin, Placebo
- Keywords
- Hepatic Encephalopathy, Acute Variceal Bleeding, Cirrhosis
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days
L-ornithine L-aspartateDrug
10 grams by intravenous way for 24 hours. Duration of therapy: 7 days
RifaximinDrug
2 tablets (400mg) three times daily. Duration of therapy: 7 days
PlaceboDrug
Placebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days.
Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days.
Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| lactulose | Experimental | Not described Receives: Drug: Lactulose |
| L-ornithine L-aspartate | Experimental | Not described Receives: Drug: L-ornithine L-aspartate |
| Rifaximin | Experimental | Not described Receives: Drug: Rifaximin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of clinical hepatic encephalopathy
Determined by West-Haven Criteria
Measured: 7 days
Secondary outcomes (1)
Development of minimal hepatic encephalopathy
Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)
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 posted6 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158182
- Sponsor's protocol ID
- DI/14/107/03/028
- Status last verified
- May 2018
- First submitted
- 4 Jun 2014
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Higuera-de-la-Tijera F, Servin-Caamano AI, Salas-Gordillo F, Perez-Hernandez JL, Abdo-Francis JM, Camacho-Aguilera J, Alla SN, Jimenez-Ponce F. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018 Jul 10;2018:3015891. doi: 10.1155/2018/3015891. eCollection 2018.
PubMed 30079329
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02158182
- Acronym / sponsor ID
- DI/14/107/03/028
- Conditions
- Hepatic Encephalopathy
- Keywords
- Hepatic Encephalopathy, Acute Variceal Bleeding, Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jun 2014 (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 aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lactulose | Experimental | Drug: Lactulose |
| L-ornithine L-aspartate | Experimental | Drug: L-ornithine L-aspartate |
| Rifaximin | Experimental | Drug: Rifaximin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria
Key exclusion criteria (1 listed)
- Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.
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 |
|---|---|---|
| Lactulose30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days | Drug | lactulose |
| L-ornithine L-aspartate10 grams by intravenous way for 24 hours. Duration of therapy: 7 days | Drug | L-ornithine L-aspartate |
| Rifaximin2 tablets (400mg) three times daily. Duration of therapy: 7 days | Drug | Rifaximin |
| PlaceboPlacebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days. Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days. Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days. | Drug | Placebo |
Primary outcome
Development of clinical hepatic encephalopathy
Time frame: 7 days
Determined by West-Haven Criteria
1 secondary outcome
Development of minimal hepatic encephalopathy
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 22 May 2018.
- Derived from this study: PubMed 30079329Higuera-de-la-Tijera F, Servin-Caamano AI, Salas-Gordillo F, Perez-Hernandez JL, Abdo-Francis JM, Camacho-Aguilera J, Alla SN, Jimenez-Ponce F. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018 Jul 10;2018:3015891. doi: 10.1155/2018/3015891. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lactulose, L-ornithine L-aspartate and Rifaximin in people with Hepatic Encephalopathy, run by Hospital General de Mexico at 1 site in Mexico.
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 1 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 22 May 2018. 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 Mexico. 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?
Development of clinical hepatic encephalopathy (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02158182, which also lists 1 linked publication.
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 22 May 2018.