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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
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00740142
First received: August 21, 2008
Last updated: June 25, 2009
Last verified: December 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

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

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

Locations
Thailand
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
Investigators
Principal Investigator: Siwaporn Chainuvati, MD Mahidol University
  More Information

No publications provided

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
Lactulose
Hepatic encephalopathy
LOLA

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion
 Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
N-Methylaspartate
Lactulose
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 23, 2013