NCT00896831

Brief Summary

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

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
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

May 11, 2009

Last Update Submit

June 5, 2009

Conditions

Hepatic Encephalopathy

Keywords

minimal hepatic encephalopathyL-ornithine-L-aspartatepsychometric testcritical flicker frequencyquality of lifeTreatmentHealth-related quality of life

Outcome Measures

Primary Outcomes (1)

  • Psychometric tests and critical flicker frequency

    day 0, 15, 30, 45 and 60

Secondary Outcomes (3)

  • Ammonia concentration

    time 0 and 60 days after

  • Health-related quality of life

    time 0 and 60 days after

  • Safety analysis

    time 0 and 60 days after

Study Arms (2)

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

L-ornithine-L-aspartateDRUG

L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days

L-ornithine-L-aspartate
placeboDRUG

Placebo: 5 g (1 sachet) three times per day for 60 days

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

ornithylaspartate

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mário R Álvares-da-Silva, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

June 10, 2009

Record last verified: 2009-06

Locations

BR(1)