Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection (R+OCA)
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|ClinicalTrials.gov Identifier: NCT03124199|
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : February 19, 2018
Last Update Posted : March 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infection Due to Helicobacter Pylori (H. Pylori)||Drug: Rifaximin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rifaximin Associated With Classic Triple Therapy (Inhibitor of Proton Pump, Amoxicillin and Clarithromycin) for the Eradication of Helicobacter Pylori Infection|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||June 2015|
Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.
Rifaximin 400 mg/8 h added to the standard triple therapy
- Percentage of Participants With H.Pylori Infection Eradication [ Time Frame: 1 month ]Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment
- Tolerability of Treatment [ Time Frame: 1 month ]Patients with side effects present during treatment and in the 4 weeks after end of treatment
- Compliance With Treatment of Patients That Completed the Study [ Time Frame: 1 month ]Percentage of patients that has comply with treatment, considered as intake of more than 90% of study drugs in patients who attended the post-treatment visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124199
|Hospital Universitario de La Princesa|
|Madrid, Spain, 28006|
|Principal Investigator:||Javier Perez, Gisbert||Fundación de Investigación Biomédica - Hospital Universitario de La Princesa|