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Last Updated: January 25, 2020

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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 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.
NCT00259155 Rifaximin for the Treatment of Irritable Bowel Syndrome Completed University of Chicago Phase 2 2003-07-01 We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
NCT00259155 Rifaximin for the Treatment of Irritable Bowel Syndrome Completed Valeant Pharmaceuticals International, Inc. Phase 2 2003-07-01 We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
NCT00259155 Rifaximin for the Treatment of Irritable Bowel Syndrome Completed Cedars-Sinai Medical Center Phase 2 2003-07-01 We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rifaximin

Condition Name

Condition Name for Rifaximin
Intervention Trials
Hepatic Encephalopathy 22
Liver Cirrhosis 13
Cirrhosis 9
Irritable Bowel Syndrome 8
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Condition MeSH

Condition MeSH for Rifaximin
Intervention Trials
Hepatic Encephalopathy 29
Brain Diseases 29
Liver Cirrhosis 23
Fibrosis 21
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Clinical Trial Locations for Rifaximin

Trials by Country

Trials by Country for Rifaximin
Location Trials
United States 375
Italy 12
China 10
United Kingdom 8
Germany 7
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Trials by US State

Trials by US State for Rifaximin
Location Trials
California 21
New York 20
Virginia 16
Texas 15
Florida 15
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Clinical Trial Progress for Rifaximin

Clinical Trial Phase

Clinical Trial Phase for Rifaximin
Clinical Trial Phase Trials
Phase 4 26
Phase 3 28
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Rifaximin
Clinical Trial Phase Trials
Recruiting 46
Completed 46
Not yet recruiting 21
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Clinical Trial Sponsors for Rifaximin

Sponsor Name

Sponsor Name for Rifaximin
Sponsor Trials
Valeant Pharmaceuticals International, Inc. 33
Alfasigma S.p.A. 4
Shanghai Zhongshan Hospital 4
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Sponsor Type

Sponsor Type for Rifaximin
Sponsor Trials
Other 159
Industry 49
U.S. Fed 16
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