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Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Biophisics Department of Biosciences Institute - Unesp
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01097811
First received: March 31, 2010
Last updated: April 27, 2010
Last verified: April 2010
History of Changes
  Purpose

Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.


Condition Intervention
Hepatic Encephalopathy
Hypertension, Portal
Liver Cirrhosis
 Drug: Erythromycin
Drug: Neomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Recovery of hepatic encephalopathy [ Time Frame: three years ] [ Designated as safety issue: No ]
    comparison of efficacy between two drugs for the treatment of hepatic encephalopathy


Secondary Outcome Measures:
  • length of hospitalization caused by hepatic encephalopathy [ Time Frame: three years ] [ Designated as safety issue: No ]
    comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy


Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Erythromycin Drug: Erythromycin
250 mg orally q.i.d.
Active Comparator: Neomycin Drug: Neomycin
1 g orally q.i.d.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatic cirrhosis or portal hypertension
  • Hepatic Encephalopathy

Exclusion Criteria:

  • Acute liver failure
  • Neuropsychiatric diseases
  • Inflammatory bowel diseases
  • Intestinal obstruction
  • Shock
  • Renal insufficiency
  • Alcoholic hepatitis
  • Alcohol abuse
  • Antibiotic premedication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097811

Locations
Brazil
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
Botucatu, São Paulo, Brazil, 18618970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Biophisics Department of Biosciences Institute - Unesp
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Fernando G Romeiro Faculdade de Medicina de Botucatu - UNESP
Study Chair: Carlos A Caramori Faculdade de Medicina de Botucatu - UNESP
  More Information

No publications provided

Responsible Party: Fernando Gomes Romeiro / Doctor, Faculdade de Medicina de Botucatu - UNESP
ClinicalTrials.gov Identifier: NCT01097811     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-41
Study First Received: March 31, 2010
Last Updated: April 27, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Hepatic Encephalopathy
Hypertension, Portal
Liver Cirrhosis
Bacterial Overgrowth Syndrome

Additional relevant MeSH terms:
Hepatic Encephalopathy
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 19, 2013