drugset / Trial / NCT02086825

A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure

NCT02086825

Phase 3 Withdrawn NYU Langone Health
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of the current study is to determine whether rifaximin or lactulose is more effective in preventing the development of severe hepatic encephalopathy in hospitalized patients with cirrhosis and new onset kidney failure. Subjects will be randomly assigned to one of two treatment groups: Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B: Rifaximin 550mg tablet twice daily. Subjects will be followed daily for two weeks or until hospital discharge. Treatment success is defined as prevention of grade 3 or 4 HE during hospitalization.

Timeline

Start
2015-10
Primary completion
2016-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactulose Other / unclassified 20 g
Subject Rifaximin Other / unclassified 550 mg