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Lactulose for Minimal Hepatic Encephalopathy in Children with Chronic Liver Disease
NCT00811434Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2009
- Primary completion
- Nov 2010
- Countries
- 1
- Sponsor
- Indiana University
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- lactulose
- Conditions
- hepatic encephalopathy (HE)
01
Overview
Phase 2, randomised, double-blind trial in hepatic encephalopathy (HE) comparing Lactulose Arm with Placebo Arm (2 arms). Primary endpoint: Incidence of Minimal Hepatic Encephalopathy. Started Jan 2009; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Lactulose Arm
Active treatment with lactulose.
Placebo Arm
Sugar water placebo.
03
Who it enrols
Pediatric patients with cirrhosis and minimal hepatic encephalopathy (MHE) diagnosed via cognitive and developmental testing.
04
Endpoints
Primary
Incidence of Minimal Hepatic Encephalopathy
Secondary
Health Related Quality of Life
Effects of Lactulose Treatment on MHE as Measured by Cognitive Function
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