Efficacy of Combined Oral L-Ornithine-L-Aspartate and Lactulose in Patients With Hepatic Encephalopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Mahidol University.
Recruitment status was  Recruiting
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
First received: August 21, 2008
Last updated: June 25, 2009
Last verified: December 2008
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

Condition Intervention Phase
Hepatic Encephalopathy
Drug: L-ornithine-L-aspartate and lactulose
Drug: placebo and lactulose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Combined Oral L-Ornithine-L-Aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • To assess improvement of mental status of the patients [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: September 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Interventional arm: oral L-ornithine-L-aspartate and oral lactulose
Drug: L-ornithine-L-aspartate and lactulose
L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
Placebo Comparator: 2
Oral lactulose
Drug: placebo and lactulose
placebo 3 times a day for 7 days

Detailed Description:

Data collection

  1. Baseline characteristics

    • demographic data; age, gender, BW, height
    • cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
    • comorbidity such as DM, CVA
  2. After randomization

    • assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
    • blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
    • record adverse effect of drug such as nausea, vomiting, bloating.
    • record diet, frequency of bowel movement and stool pH
    • compliance

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cirrhosis
  • Age 18-80
  • Hepatic encephalopathy grade II-III
  • Serum ammonia > 60 mcg/mL
  • Informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740142

Contact: Siwaporn Chainuvati, MD (662) 4197281 siswf@mahidol.ac.th

Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Siwaporn Chainuvati, MD    (662)4197281    siswf@mahidol.ac.th   
Sub-Investigator: Supot Nimanong, MD         
Principal Investigator: Siwaporn Chainuvati, MD         
Sponsors and Collaborators
Mahidol University
Principal Investigator: Siwaporn Chainuvati, MD Mahidol University
  More Information

Responsible Party: Siwaporn Chainuvati, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00740142     History of Changes
Other Study ID Numbers: Si 341/2008 
Study First Received: August 21, 2008
Last Updated: June 25, 2009
Health Authority: Thailand: Food and Drug Administration
Thailand: Ethical Committee

Keywords provided by Mahidol University:
L ornithine L aspartate
Hepatic encephalopathy

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases
Excitatory Amino Acid Agents
Excitatory Amino Acid Agonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016