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Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Rifaximin SSD 40 mg IR tablet
Rifaximin SSD 80 mg IR tablet
Rifaximin SSD 40 mg SER tablet
Rifaximin SSD 80 mg SER tablet
Rifaximin SSD 80mgIR/80mgSER tablet
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of liver cirrhosis and documented ascites.
  • Model End Stage Liver Disease (MELD) score of at least 12, MELD Na of at least 12, or Child-Pugh B (score of 7 - 9).
  • If applicable, has a close family or other personal contacts who can provide continuing oversight to the patient and will be available to the patient during the conduct of the trial.
  • If female of childbearing potential, have a negative serum pregnancy test at study start and agree to use an acceptable method of contraception during the study.

Exclusion Criteria:

  • History of a major psychiatric disorder including uncontrolled major depression or controlled or uncontrolled psychoses within the past 24 months prior to study start.
  • History of alcohol abuse or substance abuse within the past 3 months prior to study start.
  • Documented cholestatic liver disease such as primary sclerosing cholangitis.
  • Had prophylactic variceal banding within 2 weeks or is scheduled to undergo prophylactic banding during the study.
  • Diagnosed with an infection for which the patient is currently taking oral or parenteral antibiotics.
  • Significant hypovolemia, or any electrolyte abnormality that can affect mental function (eg, serum sodium < 125 mEq/L, serum calcium > 10 mg/dL).
  • Severe hypokalemia, defined as serum potassium concentration < 2.5 mEq/L.
  • Anemic, defined as hemoglobin concentration ≤ 8 g/dL.
  • Renal insufficiency with a creatinine of ≥ 1.5 mg/dL.
  • Presence of intestinal obstruction or inflammatory bowel disease.
  • Uncontrolled Type 1 or Type 2 diabetes.
  • History of seizure disorders.
  • Unstable cardiovascular or pulmonary disease, categorized by a worsening in the disease condition that requires a change in treatment or medical care within 30 days of study start.
  • Active malignancy within the last 5 years (exceptions: basal cell carcinomas of the skin, or if female, in situ cervical carcinoma that has been surgically excised).
  • Has hepatocellular carcinoma.
  • Known human immunodeficiency virus, varicella, herpes zoster, or other severe viral infection within 6 weeks of study start.
  • Positive stool test for Yersinia enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile (C. difficile); determined during the screening period prior to study start.
  • History of tuberculosis infection and/or has received treatment for a tuberculosis infection.
  • History of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin soluble solid dispersion.
  • Used any investigational product or device, or participated in another research study within 30 days prior to study start.

Sites / Locations

  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigational Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site
  • Salix Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Rifaximin SSD 40 mg IR tablet

Rifaximin SSD 80 mg IR tablet

Rifaximin SSD 40 mg SER tablet

Rifaximin SSD 80 mg SER tablet

Rifaximin SSD 80mgIR/80mgSER tablet

Arm Description

Placebo tablets once daily.

Rifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily.

Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily.

Rifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily.

Rifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily.

Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily.

Outcomes

Primary Outcome Measures

Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.

Secondary Outcome Measures

Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
This outcome measure will determine the rate of hospitalization (percentage of patients who are hospitalized) due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
Pharmacokinetics of rifaximin and its metabolite.
This outcome will measure the plasma levels of rifaximin and its metabolite (25-desacetyl rifaximin) for each patient during the 24-week treatment period.
Incidence of treatment-emergent adverse events.
This outcome will evaluate the incidence of treatment-emergent adverse events (percentage of patients who experience adverse events following the start of the treatment period).
Change in clinical laboratory parameters.
This outcome will measure the changes in each patient's clinical laboratory test results during the treatment period.
Changes in electrocardiogram measurements
This outcome will measure the changes in measurements obtained from 12-lead electrocardiograms for each patient during the treatment period.
Changes in indices of health outcomes
This outcome will evaluate each patient's responses on questionnaires that assess health status.

Full Information

First Posted
July 17, 2013
Last Updated
October 15, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01904409
Brief Title
Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
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 for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin. Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets once daily.
Arm Title
Rifaximin SSD 40 mg IR tablet
Arm Type
Experimental
Arm Description
Rifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily.
Arm Title
Rifaximin SSD 80 mg IR tablet
Arm Type
Experimental
Arm Description
Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily.
Arm Title
Rifaximin SSD 40 mg SER tablet
Arm Type
Experimental
Arm Description
Rifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily.
Arm Title
Rifaximin SSD 80 mg SER tablet
Arm Type
Experimental
Arm Description
Rifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily.
Arm Title
Rifaximin SSD 80mgIR/80mgSER tablet
Arm Type
Experimental
Arm Description
Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD 40 mg IR tablet
Other Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD 80 mg IR tablet
Other Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD 40 mg SER tablet
Other Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD 80 mg SER tablet
Other Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD 80mgIR/80mgSER tablet
Other Intervention Name(s)
Rifaximin
Primary Outcome Measure Information:
Title
Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.
Description
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.
Time Frame
Weeks 1 through 24
Secondary Outcome Measure Information:
Title
Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
Description
This outcome measure will determine the rate of hospitalization (percentage of patients who are hospitalized) due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
Time Frame
Weeks 1 through 24
Title
Pharmacokinetics of rifaximin and its metabolite.
Description
This outcome will measure the plasma levels of rifaximin and its metabolite (25-desacetyl rifaximin) for each patient during the 24-week treatment period.
Time Frame
Weeks 1 through 24
Title
Incidence of treatment-emergent adverse events.
Description
This outcome will evaluate the incidence of treatment-emergent adverse events (percentage of patients who experience adverse events following the start of the treatment period).
Time Frame
Weeks 1 through 24
Title
Change in clinical laboratory parameters.
Description
This outcome will measure the changes in each patient's clinical laboratory test results during the treatment period.
Time Frame
Weeks 1 through 24
Title
Changes in electrocardiogram measurements
Description
This outcome will measure the changes in measurements obtained from 12-lead electrocardiograms for each patient during the treatment period.
Time Frame
Weeks 1 through 24
Title
Changes in indices of health outcomes
Description
This outcome will evaluate each patient's responses on questionnaires that assess health status.
Time Frame
Weeks, 4, 8, 12, 16, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of liver cirrhosis and documented ascites. Model End Stage Liver Disease (MELD) score of at least 12, MELD Na of at least 12, or Child-Pugh B (score of 7 - 9). If applicable, has a close family or other personal contacts who can provide continuing oversight to the patient and will be available to the patient during the conduct of the trial. If female of childbearing potential, have a negative serum pregnancy test at study start and agree to use an acceptable method of contraception during the study. Exclusion Criteria: History of a major psychiatric disorder including uncontrolled major depression or controlled or uncontrolled psychoses within the past 24 months prior to study start. History of alcohol abuse or substance abuse within the past 3 months prior to study start. Documented cholestatic liver disease such as primary sclerosing cholangitis. Had prophylactic variceal banding within 2 weeks or is scheduled to undergo prophylactic banding during the study. Diagnosed with an infection for which the patient is currently taking oral or parenteral antibiotics. Significant hypovolemia, or any electrolyte abnormality that can affect mental function (eg, serum sodium < 125 mEq/L, serum calcium > 10 mg/dL). Severe hypokalemia, defined as serum potassium concentration < 2.5 mEq/L. Anemic, defined as hemoglobin concentration ≤ 8 g/dL. Renal insufficiency with a creatinine of ≥ 1.5 mg/dL. Presence of intestinal obstruction or inflammatory bowel disease. Uncontrolled Type 1 or Type 2 diabetes. History of seizure disorders. Unstable cardiovascular or pulmonary disease, categorized by a worsening in the disease condition that requires a change in treatment or medical care within 30 days of study start. Active malignancy within the last 5 years (exceptions: basal cell carcinomas of the skin, or if female, in situ cervical carcinoma that has been surgically excised). Has hepatocellular carcinoma. Known human immunodeficiency virus, varicella, herpes zoster, or other severe viral infection within 6 weeks of study start. Positive stool test for Yersinia enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile (C. difficile); determined during the screening period prior to study start. History of tuberculosis infection and/or has received treatment for a tuberculosis infection. History of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin soluble solid dispersion. Used any investigational product or device, or participated in another research study within 30 days prior to study start.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Joffrion
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Salix Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Salix Investigative Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Salix Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Salix Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Salix Investigational Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Salix Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Salix Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Salix Investigational Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Salix Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Salix Investigative Site
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Salix Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Salix Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Salix Investigational Site
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Salix Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Salix Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Salix Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Salix Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Salix Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Salix Investigational Site
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06035
Country
United States
Facility Name
Salix Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Salix Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Salix Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Salix Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Salix Investigative Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Salix Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Salix Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Salix Investigative Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Salix Investigational Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Salix Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Salix Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Salix Investigational Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Salix Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Salix Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Salix Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Salix Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Salix Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32824
Country
United States
Facility Name
Salix Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Salix Investigational Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Salix Investigational Site
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Salix Investigational Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Salix Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Salix Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Salix Investigative Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Salix Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Salix Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Salix Investigative Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
75390
Country
United States
Facility Name
Salix Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Salix Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Salix Investigative Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Salix Investigational Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Salix Investigational Site
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Salix Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Salix Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Salix Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Salix Investigational Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Salix Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Salix Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Salix Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Salix Investigational Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21743
Country
United States
Facility Name
Salix Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Salix Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Salix Investigational Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Salix Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Salix Investigative Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Salix Investigational Site
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Salix Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Salix Investigative Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Salix Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Salix Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Salix Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Salix Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Salix Investigative Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Salix Investigative Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
60153
Country
United States
Facility Name
Salix Investigational Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Salix Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Salix Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Salix Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Salix Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Salix Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Salix Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Salix Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Salix Investigational Site
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Salix Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Salix Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Salix Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Salix Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Salix Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Salix Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Salix Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Salix Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Salix Investigative Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Salix Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Salix Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Salix Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Salix Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Salix Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Salix Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Salix Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Salix Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Salix Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Salix Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Salix Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Salix Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Salix Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Salix Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Salix Investigational Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Salix Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Salix Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Salix Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Salix Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Salix Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Salix Investigative Site
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Salix Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Salix Investigative Site
City
Krasnogorsk
Country
Russian Federation
Facility Name
Salix Investigative Site
City
Moscow
Country
Russian Federation
Facility Name
Salix Investigative Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Salix Investigative Site
City
Petersburg
Country
Russian Federation
Facility Name
Salix Investigative Site
City
Samara
Country
Russian Federation
Facility Name
Salix Investigative Site
City
Smolensk
Country
Russian Federation
Facility Name
Salix Investigative Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Salix Investigative Site
City
Stavropol
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
35750249
Citation
Bajaj JS, Hassanein TI, Pyrsopoulos NT, Sanyal AJ, Rahimi RS, Heimanson Z, Israel RJ, Rockey DC. Dosing of Rifaximin Soluble Solid Dispersion Tablets in Adults With Cirrhosis: 2 Randomized, Placebo-controlled Trials. Clin Gastroenterol Hepatol. 2023 Mar;21(3):723-731.e9. doi: 10.1016/j.cgh.2022.05.042. Epub 2022 Jun 22.
Results Reference
derived

Learn more about this trial

Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis

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