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

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ClinicalTrials.gov Identifier: NCT00740142
Recruitment Status : Unknown
Verified December 2008 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : August 22, 2008
Last Update Posted : June 26, 2009
Sponsor:
Information provided by:
Mahidol University

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

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: L-ornithine-L-aspartate and lactulose Drug: placebo and lactulose Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Combined Oral L-Ornithine-L-Aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy
Study Start Date : September 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : August 2010


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To assess improvement of mental status of the patients [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Siwaporn Chainuvati, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00740142     History of Changes
Other Study ID Numbers: Si 341/2008
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: June 26, 2009
Last Verified: December 2008

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

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