Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00740142
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 35 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: Sep 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To assess improvement of mental status of the patients [7 days]

Secondary Outcome Measures

1. To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Siwaporn Chainuvati, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT00740142
• Other Study ID Numbers: Si 341/2008
• First Posted: Aug 22, 2008
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Mahidol University: L ornithine L aspartate; Lactulose; Hepatic encephalopathy; LOLA
• Additional relevant MeSH terms: Hepatic Encephalopathy; Brain Diseases; Lactulose; N-Methylaspartate

Study Results

No Results Posted as of Sep 4, 2020