Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on M... | NCT00896831

Studies
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy

NCT00896831

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Jun 10, 2009Estimated

Enrollment

96Estimated

Phase

Phase 4

Conditions

Hepatic Encephalopathy

Interventions

L-ornithine-L-aspartate
placebo

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 11, 2009

First Posted Date

May 12, 2009Estimated

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

Jun 5, 2009

Last Update Posted Date

Jun 10, 2009Estimated

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

The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.

Detailed Description

Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
L-ornithine-L-aspartate	Active Comparator	5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days	Drug: L-ornithine-L-aspartate
placebo	Placebo Comparator	5 g (1 sachet) of placebo comparator three times per day for 60 days	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-ornithine-L-aspartate	Drug	L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days	L-ornithine-L-aspartate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychometric tests and critical flicker frequency		day 0, 15, 30, 45 and 60

Secondary Outcomes

Measure	Description	Time Frame
Ammonia concentration		time 0 and 60 days after
Health-related quality of life		time 0 and 60 days after
Safety analysis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency

Exclusion Criteria:

Hepatic encephalopathy grade 1 to 4
Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
Psychoactive substance use within 72 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Mário R Álvares-da-Silva, PhD	Hospital de Clínicas de Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006501	Hepatic Encephalopathy

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
C002939	ornithylaspartate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided