NCT01097811

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

March 31, 2010

Last Update Submit

April 27, 2010

Conditions

Hepatic EncephalopathyHypertension, PortalLiver Cirrhosis

Keywords

Hepatic EncephalopathyHypertension, PortalLiver CirrhosisBacterial Overgrowth Syndrome

Outcome Measures

Primary Outcomes (1)

  • Recovery of hepatic encephalopathy

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

    three years

Secondary Outcomes (1)

  • length of hospitalization caused by hepatic encephalopathy

    three years

Study Arms (2)

Erythromycin

ACTIVE COMPARATOR
Drug: Erythromycin

Neomycin

ACTIVE COMPARATOR
Drug: Neomycin

Interventions

ErythromycinDRUG

250 mg orally q.i.d.

Erythromycin
NeomycinDRUG

1 g orally q.i.d.

Neomycin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatic cirrhosis or portal hypertension
  • Hepatic Encephalopathy

You may not qualify if:

  • Acute liver failure
  • Neuropsychiatric diseases
  • Inflammatory bowel diseases
  • Intestinal obstruction
  • Shock
  • Renal insufficiency
  • Alcoholic hepatitis
  • Alcohol abuse
  • Antibiotic premedication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

Botucatu, São Paulo, 18618970, Brazil

Location

MeSH Terms

Conditions

Hepatic EncephalopathyHypertension, PortalLiver CirrhosisBlind Loop Syndrome

Interventions

ErythromycinNeomycin

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsMalabsorption SyndromesIntestinal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Fernando G Romeiro

    Faculdade de Medicina de Botucatu, Unesp

    PRINCIPAL INVESTIGATOR

  • Carlos A Caramori

    Faculdade de Medicina de Botucatu, Unesp

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 2, 2010

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

April 28, 2010

Record last verified: 2010-04

Locations

BR(1)