NCT03515044

Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).

Detailed description

The primary objective of this study is to assess the efficacy of rifaximin SSD plus lactulose versus placebo plus lactulose for the treatment of overt hepatic encephalopathy (OHE). The secondary objectives of this study are to assess the safety of rifaximin SSD in subjects with OHE and to assess the effects of treatment with rifaximin SSD on key secondary endpoints.

Conditions

• Overt Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	40 mg Rifaximin SSD once daily	SSD once daily (QD)
DRUG	40 mg Rifaximin SSD twice daily	SSD twice daily (BID)
DRUG	80 mg Rifaximin SSD once daily	SSD once daily (QD)
DRUG	80 mg Rifaximin SSD twice daily	SSD twice daily (BID)
DRUG	Placebo	Administered twice daily (BID)

Timeline

• Start date: 2018-09-13
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2018-05-03
• Last updated: 2023-04-13
• Results posted: 2023-04-13

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study