Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
Public ClinicalTrials.gov record NCT01904409. 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.
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 for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01904409
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Rifaximin SSD 40 mg IR tablet Drug
- Rifaximin SSD 80 mg IR tablet Drug
- Rifaximin SSD 40 mg SER tablet Drug
- Rifaximin SSD 80 mg SER tablet Drug
- Rifaximin SSD 80mgIR/80mgSER tablet Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2013 (Type not available)
- Primary completion
- Jun 2015 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Oct 23, 2019
2013 – 2015
United States locations
- U.S. sites
- 113
- U.S. states
- 28
- U.S. cities
- 97
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Salix Investigative Site | Birmingham | Alabama | 35294 | — |
| Salix Investigative Site | Dothan | Alabama | 36305 | — |
| Salix Investigative Site | Mobile | Alabama | 36617 | — |
| Salix Investigative Site | Tucson | Arizona | 85712 | — |
| Salix Investigational Site | Artesia | California | 90701 | — |
| Salix Investigational Site | Bakersfield | California | 93301 | — |
| Salix Investigational Site | Chula Vista | California | 91910 | — |
| Salix Investigational Site | Coronado | California | 92118 | — |
| Salix Investigational Site | Costa Mesa | California | 92626 | — |
| Salix Investigative Site | Fresno | California | 93701 | — |
| Salix Investigational Site | La Jolla | California | 92037 | — |
| Salix Investigative Site | Los Angeles | California | 90033 | — |
| Salix Investigational Site | Monterey | California | 93940 | — |
| Salix Investigational Site | Riverside | California | 92377 | — |
| Salix Investigational Site | San Diego | California | 92114 | — |
| Salix Investigational Site | Ventura | California | 93003 | — |
| Salix Investigational Site | Englewood | Colorado | 80113 | — |
| Salix Investigational Site | Littleton | Colorado | 80120 | — |
| Salix Investigational Site | Bristol | Connecticut | 06035 | — |
| Salix Investigational Site | New Haven | Connecticut | 06520 | — |
| Salix Investigational Site | Waterbury | Connecticut | 06708 | — |
| Salix Investigational Site | Coral Gables | Florida | 33134 | — |
| Salix Investigational Site | Gainesville | Florida | 32610 | — |
| Salix Investigative Site | Hialeah | Florida | 33012 | — |
| Salix Investigational Site | Hialeah | Florida | 33016 | — |
| Salix Investigational Site | Hollywood | Florida | 33021 | — |
| Salix Investigative Site | Inverness | Florida | 34452 | — |
| Salix Investigational Site | Lake Worth | Florida | 33449 | — |
| Salix Investigative Site | Largo | Florida | 33777 | — |
| Salix Investigative Site | Maitland | Florida | 32751 | — |
| Salix Investigational Site | Miami | Florida | 33030 | — |
| Salix Investigational Site | Miami | Florida | 33126 | — |
| Salix Investigational Site | Miami | Florida | 33136 | — |
| Salix Investigational Site | Miami Springs | Florida | 33166 | — |
| Salix Investigational Site | New Port Richey | Florida | 34653 | — |
| Salix Investigative Site | Orlando | Florida | 32824 | — |
| Salix Investigational Site | Pembroke Pines | Florida | 33024 | — |
| Salix Investigational Site | Port Orange | Florida | 32127 | — |
| Salix Investigational Site | Saint Cloud | Florida | 34769 | — |
| Salix Investigational Site | Tamarac | Florida | 33319 | — |
| Salix Investigational Site | Atlanta | Georgia | 30309 | — |
| Salix Investigative Site | Atlanta | Georgia | 30342 | — |
| Salix Investigative Site | Decatur | Georgia | 30033 | — |
| Salix Investigational Site | Macon | Georgia | 31201 | — |
| Salix Investigative Site | Chicago | Illinois | 60612 | — |
| Salix Investigative Site | Maywood | Illinois | 75390 | — |
| Salix Investigational Site | Evansville | Indiana | 47714 | — |
| Salix Investigational Site | Indianapolis | Indiana | 46202 | — |
| Salix Investigative Site | Iowa City | Iowa | 52242 | — |
| Salix Investigational Site | Bowling Green | Kentucky | 42101 | — |
| Salix Investigational Site | Bastrop | Louisiana | 71220 | — |
| Salix Investigational Site | Monroe | Louisiana | 71201 | — |
| Salix Investigational Site | New Orleans | Louisiana | 70112 | — |
| Salix Investigational Site | Shreveport | Louisiana | 71103 | — |
| Salix Investigational Site | Annapolis | Maryland | 21401 | — |
| Salix Investigational Site | Baltimore | Maryland | 21202 | — |
| Salix Investigational Site | Baltimore | Maryland | 21228 | — |
| Salix Investigational Site | Chevy Chase | Maryland | 20815 | — |
| Salix Investigational Site | Hagerstown | Maryland | 21743 | — |
| Salix Investigational Site | Boston | Massachusetts | 02114 | — |
| Salix Investigational Site | Boston | Massachusetts | 02115 | — |
| Salix Investigational Site | Brockton | Massachusetts | 02302 | — |
| Salix Investigational Site | Springfield | Massachusetts | 01105 | — |
| Salix Investigative Site | Chesterfield | Michigan | 48047 | — |
| Salix Investigational Site | Wyoming | Michigan | 49519 | — |
| Salix Investigational Site | Minneapolis | Minnesota | 55455 | — |
| Salix Investigative Site | Tupelo | Mississippi | 38801 | — |
| Salix Investigational Site | Kansas City | Missouri | 64131 | — |
| Salix Investigative Site | St Louis | Missouri | 63110 | — |
| Salix Investigational Site | Marlton | New Jersey | 08053 | — |
| Salix Investigational Site | New Brunswick | New Jersey | 07102 | — |
| Salix Investigative Site | Brooklyn | New York | 60153 | — |
| Salix Investigational Site | Flushing | New York | 11040 | — |
| Salix Investigational Site | New York | New York | 10016 | — |
| Salix Investigational Site | New York | New York | 10032 | — |
| Salix Investigational Site | Rochester | New York | 14642 | — |
| Salix Investigative Site | The Bronx | New York | 10467 | — |
| Salix Investigational Site | Asheville | North Carolina | 28801 | — |
| Salix Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Salix Investigative Site | Charlotte | North Carolina | 28204 | — |
| Salix Investigational Site | Charlotte | North Carolina | 28207 | — |
| Salix Investigational Site | Fayetteville | North Carolina | 28304 | — |
| Salix Investigational Site | Wilmington | North Carolina | 28403 | — |
| Salix Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Salix Investigative Site | Cincinnati | Ohio | 45224 | — |
| Salix Investigational Site | Cincinnati | Ohio | 45249 | — |
| Salix Investigational Site | Cleveland | Ohio | 44195 | — |
| Salix Investigative Site | Dayton | Ohio | 45415 | — |
| Salix Investigational Site | Mentor | Ohio | 44060 | — |
| Salix Investigational Site | Portland | Oregon | 97210 | — |
| Salix Investigative Site | Bristol | Tennessee | 37620 | — |
| Salix Investigational Site | Chattanooga | Tennessee | 37421 | — |
| Salix Investigational Site | Nashville | Tennessee | 37205 | — |
| Salix Investigational Site | Nashville | Tennessee | 37211 | — |
| Salix Investigative Site | Arlington | Texas | 76012 | — |
| Salix Investigational Site | Austin | Texas | 78705 | — |
| Salix Investigational Site | Dallas | Texas | 75203 | — |
| Salix Investigational Site | Dallas | Texas | 75246 | — |
| Salix Investigative Site | Dallas | Texas | 75390 | — |
| Salix Investigational Site | Fort Worth | Texas | 76104 | — |
| Salix Investigational Site | Houston | Texas | 77005 | — |
| Salix Investigational Site | Houston | Texas | 77030 | — |
| Salix Investigational Site | Houston | Texas | 77090 | — |
| Salix Investigational Site | San Antonio | Texas | 78215 | — |
| Salix Investigational Site | San Antonio | Texas | 78229 | — |
| Salix Investigational Site | Bountiful | Utah | 84010 | — |
| Salix Investigative Site | Salt Lake City | Utah | 84132 | — |
| Salix Investigational Site | Charlottesville | Virginia | 22908 | — |
| Salix Investigative Site | Norfolk | Virginia | 23502 | — |
| Salix Investigative Site | Richmond | Virginia | 23249 | — |
| Salix Investigational Site | Richmond | Virginia | 23298 | — |
| Salix Investigative Site | Richland | Washington | 99352 | — |
| Salix Investigative Site | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01904409, 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 Oct 23, 2019 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01904409 live on ClinicalTrials.gov.