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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR RIFAXIMIN


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505(b)(2) Clinical Trials for Rifaximin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03124199 ↗ Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection Completed Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Phase 3 2014-02-01 Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Rifaximin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00098384 ↗ Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea Completed Bausch Health Americas, Inc. Phase 2 2003-06-01 The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00098384 ↗ Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea Completed The University of Texas Health Science Center, Houston Phase 2 2003-06-01 The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00098384 ↗ Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea Completed Valeant Pharmaceuticals International, Inc. Phase 2 2003-06-01 The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00098384 ↗ Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea Completed DuPont, Hurbert L., MD Phase 2 2003-06-01 The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rifaximin

Condition Name

Condition Name for Rifaximin
Intervention Trials
Hepatic Encephalopathy 27
Liver Cirrhosis 14
Irritable Bowel Syndrome 11
Small Intestinal Bacterial Overgrowth 9
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Condition MeSH

Condition MeSH for Rifaximin
Intervention Trials
Hepatic Encephalopathy 35
Brain Diseases 35
Liver Cirrhosis 25
Fibrosis 24
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Clinical Trial Locations for Rifaximin

Trials by Country

Trials by Country for Rifaximin
Location Trials
United States 405
Italy 13
China 12
Mexico 9
India 9
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Trials by US State

Trials by US State for Rifaximin
Location Trials
California 25
New York 21
Florida 19
Virginia 17
Texas 16
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Clinical Trial Progress for Rifaximin

Clinical Trial Phase

Clinical Trial Phase for Rifaximin
Clinical Trial Phase Trials
Phase 4 30
Phase 3 31
Phase 2/Phase 3 11
[disabled in preview] 34
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Clinical Trial Status

Clinical Trial Status for Rifaximin
Clinical Trial Phase Trials
Completed 70
Unknown status 27
Recruiting 26
[disabled in preview] 16
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Clinical Trial Sponsors for Rifaximin

Sponsor Name

Sponsor Name for Rifaximin
Sponsor Trials
Bausch Health Americas, Inc. 36
Valeant Pharmaceuticals International, Inc. 33
Alfasigma S.p.A. 7
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Sponsor Type

Sponsor Type for Rifaximin
Sponsor Trials
Other 195
Industry 93
U.S. Fed 18
[disabled in preview] 7
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