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Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Erythromycin
Neomycin
Sponsored by
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis, Bacterial Overgrowth Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erythromycin

Neomycin

Arm Description

Outcomes

Primary Outcome Measures

Recovery of hepatic encephalopathy
comparison of efficacy between two drugs for the treatment of hepatic encephalopathy

Secondary Outcome Measures

length of hospitalization caused by hepatic encephalopathy
comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy

Full Information

First Posted
March 31, 2010
Last Updated
April 27, 2010
Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Biophisics Department of Biosciences Institute - Unesp, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01097811
Brief Title
Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy
Official Title
Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Biophisics Department of Biosciences Institute - Unesp, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis
Keywords
Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis, Bacterial Overgrowth Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythromycin
Arm Type
Active Comparator
Arm Title
Neomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Description
250 mg orally q.i.d.
Intervention Type
Drug
Intervention Name(s)
Neomycin
Intervention Description
1 g orally q.i.d.
Primary Outcome Measure Information:
Title
Recovery of hepatic encephalopathy
Description
comparison of efficacy between two drugs for the treatment of hepatic encephalopathy
Time Frame
three years
Secondary Outcome Measure Information:
Title
length of hospitalization caused by hepatic encephalopathy
Description
comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando G Romeiro
Organizational Affiliation
Faculdade de Medicina de Botucatu, Unesp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos A Caramori
Organizational Affiliation
Faculdade de Medicina de Botucatu, Unesp
Official's Role
Study Chair
Facility Information:
Facility Name
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618970
Country
Brazil

12. IPD Sharing Statement

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Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

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