Comparison Between Erythromycin and Neomycin Treatment of... | NCT01097811

Studies
Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

NCT01097811

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Unknown status

Last Update Posted

Apr 28, 2010Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Hepatic Encephalopathy
Hypertension, Portal
Liver Cirrhosis

Interventions

Erythromycin
Neomycin

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Mar 31, 2010

First Posted Date

Apr 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2010

Last Update Posted Date

Apr 28, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

UPECLIN HC FM Botucatu UnespOTHER

Collaborators

Name	Class
Biophisics Department of Biosciences Institute - Unesp	UNKNOWN
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erythromycin	Active Comparator		Drug: Erythromycin
Neomycin	Active Comparator		Drug: Neomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erythromycin	Drug	250 mg orally q.i.d.	Erythromycin
Neomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery of hepatic encephalopathy	comparison of efficacy between two drugs for the treatment of hepatic encephalopathy	three years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernando G Romeiro	Faculdade de Medicina de Botucatu, Unesp	Principal Investigator
Carlos A Caramori	Faculdade de Medicina de Botucatu, Unesp	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista		Botucatu	São Paulo	18618970	Brazil

Type	Date	Date Unknown
Release	Oct 9, 2018
Reset	Feb 20, 2019

Submission Tracking

Estimated Results First Submitted Date

Oct 9, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 9, 2018			Feb 20, 2019

Condition Browse Module

MeSH Terms

ID	Term
D006501	Hepatic Encephalopathy
D006975	Hypertension, Portal
D008103	Liver Cirrhosis
D001765	Blind Loop Syndrome

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004917	Erythromycin
D009355	Neomycin

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided