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

NCT03515044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2023-04-13

Study results available
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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).

Conditions

  • Overt Hepatic Encephalopathy

Interventions

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)

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Angela Bulawski · Bausch Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2020-03-12
Completion
2020-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03515044 on ClinicalTrials.gov