Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
1 other identifier
interventional
35
1 country
1
Brief Summary
Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedSeptember 4, 2020
September 1, 2020
1.9 years
August 21, 2008
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess improvement of mental status of the patients
7 days
Secondary Outcomes (1)
To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients
7 days
Study Arms (2)
1
ACTIVE COMPARATORInterventional arm: oral L-ornithine-L-aspartate and oral lactulose
2
PLACEBO COMPARATOROral lactulose
Interventions
L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
Eligibility Criteria
You may qualify if:
- Cirrhosis
- Age 18-80
- Hepatic encephalopathy grade II-III
- Serum ammonia \> 60 mcg/mL
- Informed consent
You may not qualify if:
- Recent GI hemorrhage
- Severe sepsis
- Degenerative CNS disease or major psychiatric illness
- Serum creatinine \> 1.5 mg/dl
- Pregnancy or lactation
- Poorly controlled DM
- Insertion of TIPS
- Received CNS depressants or hypnotics
- Treatment with metronidazole, kanamycin or branched-chain amino acid
- Hypersensitivity to L-ornithine-L-aspartate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siwaporn Chainuvati, MD
Mahidol University
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2008
First Posted
August 22, 2008
Study Start
September 1, 2008
Primary Completion
August 1, 2010
Study Completion
October 1, 2011
Last Updated
September 4, 2020
Record last verified: 2020-09