Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Liver Cirrhosis Clinical Trial

Official title:

Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01097811
• Other study ID #: upeclin/HC/FMB-Unesp-41
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2010
• Last updated: April 27, 2010
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Hypertension, Portal
• Liver Cirrhosis

Intervention

Drug:
• Erythromycin
250 mg orally q.i.d.
• Neomycin
1 g orally q.i.d.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Botucatu - Universidade Estadual Paulista	Botucatu	São Paulo

Sponsors (3)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of hepatic encephalopathy	comparison of efficacy between two drugs for the treatment of hepatic encephalopathy	three years	No
Secondary	length of hospitalization caused by hepatic encephalopathy	comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy	three years	No