CLINICAL TRIALS PROFILE FOR RIFAXIMIN

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.

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.
NCT00259155 ↗	Rifaximin for the Treatment of Irritable Bowel Syndrome	Completed	Bausch Health Americas, 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	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.

Clinical Trial Conditions for RIFAXIMIN

Condition Name

Condition Name for RIFAXIMIN
Intervention	Trials
Hepatic Encephalopathy	30
Liver Cirrhosis	15
Irritable Bowel Syndrome	11
Cirrhosis	9

Condition MeSH

Condition MeSH for RIFAXIMIN
Intervention	Trials
Hepatic Encephalopathy	38
Brain Diseases	38
Liver Cirrhosis	27
Fibrosis	25

Clinical Trial Locations for RIFAXIMIN

Trials by Country

Trials by Country for RIFAXIMIN
Location	Trials
United States	405
China	14
Italy	13
India	11
Mexico	9

Trials by US State

Trials by US State for RIFAXIMIN
Location	Trials
California	25
New York	21
Florida	19
Virginia	17
Texas	16

Clinical Trial Progress for RIFAXIMIN

Clinical Trial Phase

Clinical Trial Phase for RIFAXIMIN
Clinical Trial Phase	Trials
Phase 4	32
Phase 3	31
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for RIFAXIMIN
Clinical Trial Phase	Trials
Completed	71
Recruiting	30
Unknown status	27

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

Sponsor Type

Sponsor Type for RIFAXIMIN
Sponsor	Trials
Other	210
Industry	93
U.S. Fed	19