Hepatic EncephalopathyNCT01097811
Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy
A study testing Erythromycin and Neomycin in people with Hepatic Encephalopathy and Hypertension, Portal, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis
- What is being tested?
- Erythromycin and Neomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Dec 2010
- Phase
- Interventional
- 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
- Hepatic cirrhosis or portal hypertension
- Hepatic Encephalopathy
Who cannot join
- Acute liver failure
- Neuropsychiatric diseases
- Inflammatory bowel diseases
- Intestinal obstruction
- Shock
- Renal insufficiency
Show all 9Show fewer
- Alcoholic hepatitis
- Alcohol abuse
- Antibiotic premedication
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
Botucatu, São Paulo, 18618970
About this study
Official title: Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.
Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.
- Being tested
- Erythromycin, Neomycin
- Keywords
- Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis, Bacterial Overgrowth Syndrome
- Medical subject headings
- Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis, Blind Loop Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
250 mg orally q.i.d.
NeomycinDrug
1 g orally q.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Active comparator | Not described Receives: Drug: Erythromycin |
| Neomycin | Active comparator | Not described Receives: Drug: Neomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of hepatic encephalopathy
comparison of efficacy between two drugs for the treatment of hepatic encephalopathy
Measured: three years
Secondary outcomes (1)
length of hospitalization caused by hepatic encephalopathy
comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2010 (estimated)
- Study completionDec 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Biophisics Department of Biosciences Institute - Unesp, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Fernando G Romeiro, Principal investigator, Faculdade de Medicina de Botucatu, UnespCarlos A Caramori, Study chair, Faculdade de Medicina de Botucatu, Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097811
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-41
- Status last verified
- Apr 2010
- First submitted
- 31 Mar 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01097811
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-41
- Keywords
- Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis, Bacterial Overgrowth Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Biophisics Department of Biosciences Institute - Unesp, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Apr 2010 (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.
Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Active comparator | Drug: Erythromycin |
| Neomycin | Active comparator | Drug: Neomycin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hepatic cirrhosis or portal hypertension
- Hepatic Encephalopathy
Key exclusion criteria (9 listed)
- Acute liver failure
- Neuropsychiatric diseases
- Inflammatory bowel diseases
- Intestinal obstruction
- Shock
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 |
|---|---|---|
| Erythromycin250 mg orally q.i.d. | Drug | Erythromycin |
| Neomycin1 g orally q.i.d. | Drug | Neomycin |
Primary outcome
Recovery of hepatic encephalopathy
Time frame: three years
comparison of efficacy between two drugs for the treatment of hepatic encephalopathy
1 secondary outcome
length of hospitalization caused by hepatic encephalopathy
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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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.
Fernando G Romeiro principal investigator
Faculdade de Medicina de Botucatu, Unesp
Carlos A Caramori study chair
Faculdade de Medicina de Botucatu, Unesp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythromycin and Neomycin in people with Hepatic Encephalopathy and Hypertension, Portal, run by UPECLIN HC FM Botucatu Unesp 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 2 inclusion and 9 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 28 Apr 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Recovery of hepatic encephalopathy (time frame: three years). 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 28 Apr 2010.