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

Sponsor:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00740142

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 IV

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:

Drug Information available for: Aspartic acid Ornithine Lactulose

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

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
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 February 09, 2012