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Completed Phase 2 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT03515044

Public ClinicalTrials.gov record NCT03515044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT03515044
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
71 participants

Conditions and interventions

Interventions

  • 40 mg Rifaximin SSD once daily Drug
  • 40 mg Rifaximin SSD twice daily Drug
  • 80 mg Rifaximin SSD once daily Drug
  • 80 mg Rifaximin SSD twice daily Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 12, 2018
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020
Last update posted
Apr 12, 2023

2018 – 2020

United States locations

U.S. sites
34
U.S. states
18
U.S. cities
24
Facility City State ZIP Site status
Bausch Health Site 18 Corona del Mar California 92118
Bausch Health Site 15 Los Angeles California 90033
Bausch Health Site 19 Los Angeles California 90048
Bausch Health Site 04 San Francisco California 94143
Bausch Health Site 13 Bristol Connecticut 06010
Bausch Health Site 08 Miami Florida 33136
Bausch Health Site 05 Chicago Illinois 60611
Bausch Health Site 33 Iowa City Iowa 52242
Bausch Health Site 03 Boston Massachusetts 02215
Bausch Health Site 07 Detroit Michigan 48109
Bausch Health 01 Detroit Michigan 48127
Bausch Health Site 25 Tupelo Mississippi 38801
Bausch Health Site 24 St Louis Missouri 63104
Bausch Health Site 27 Newark New Jersey 07102
Bausch Health Site 36 Brooklyn New York 11215
Bausch Health Site 09 New York New York 10029
Bausch Health Site 28 New York New York 10065
Bausch Health Site 17 Cincinnati Ohio 45219
Bausch Health Site 23 Columbus Ohio 43210
Bausch Health Site 11 Philadelphia Pennsylvania 19104
Bausch Health Site 26 Philadelphia Pennsylvania 19107
Bausch Health Site 10 Philadelphia Pennsylvania 19141
Bausch Health Site 12 Pittsburgh Pennsylvania 15213
Bausch Health Site 16 Charleston South Carolina 29425
Bausch Health Site 22 Dallas Texas 75203
Bausch Health Site 35 Dallas Texas 75246
Bausch Health Site 31 Dallas Texas 75390
Bausch Health Site 02 Houston Texas 77001
Bausch Health Site 37 Houston Texas 77030
Bausch Health Site 30 Richmond Virginia 23226
Bausch Health Site 06 Richmond Virginia 23249
Bausch Health Site 21 Seattle Washington 98104
Bausch Health Site 14 Seattle Washington 98195
Bausch Health Site 20 Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03515044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2023 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03515044 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →