CLINICAL TRIALS PROFILE FOR RIFAXIMIN
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505(b)(2) Clinical Trials for rifaximin
| 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 | >Sponsor | >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. |
| 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. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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