Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

• Sponsor: UPECLIN HC FM Botucatu Unesp (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01097811
• Collaborator: Biophisics Department of Biosciences Institute - Unesp (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy; Hypertension, Portal; Liver Cirrhosis	Drug: Erythromycin; Drug: Neomycin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.
• Study Start Date: Jun 1, 2008
• Anticipated Primary Completion Date: Jun 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erythromycin	Drug: Erythromycin; 250 mg orally q.i.d.
Active Comparator: Neomycin	Drug: Neomycin; 1 g orally q.i.d.

Outcome Measures

Primary Outcome Measures

1. Recovery of hepatic encephalopathy [three years]

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

Secondary Outcome Measures

1. length of hospitalization caused by hepatic encephalopathy [three years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01097811
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-41
• First Posted: Apr 2, 2010
• Last Update Posted: Apr 28, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Hepatic Encephalopathy; Hypertension, Portal; Liver Cirrhosis; Bacterial Overgrowth Syndrome
• Additional relevant MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Hypertension, Portal; Brain Diseases; Hypertension; Fibrosis; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Neomycin

Study Results

No Results Posted as of Apr 28, 2010