Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Hepatic Encephalopathy
Interventions
DRUG

L-ornithine-L-aspartate

a) Intravenous infusion of 20 g L-ornithine-L-aspartate (4 ampules of 10 mL each) in 250 mL sodium chloride solution administered daily in 4 hours for 3 consecutive days, plus the placebo b) Water enemas, 1000 mL of water and given as retention enema every 12 hours for 3 consecutive days.

DRUG

Lactose

a) 20% Lactose enemas, 200 g Lactose diluted with 700 mL of water and given as retention enema every 12 hours for 3 consecutive days, plus intravenous placebo b)250 mL sodium chloride solution, infusion for 4 hours for 3 consecutive days.

Trial Locations (1)

64460

"Hospital Universitario José Eleuterio González", Monterrey

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MERZ PHARMA

UNKNOWN

lead

Centro Regional para el Estudio de las Enfermedades Digestivas

OTHER