At a glance
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A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection
In Brief
A Phase 3 clinical trial evaluating RHB-105 and Active Comparator for Helicobacter Pylori Infection and Dyspepsia. Completed, enrolled 455 participants across 55 sites.
Detailed Summary
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients against an active comparator.
Study Details
Timeline
Interventions
The intended dose of RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, is equivalent to a total daily dose of: * Rifabutin 150 mg * Amoxicillin 3000 mg * Omeprazole 120 mg One 50mg Riboflavin tablet to be taken once daily to maintain the blind.
The intended dose of the Active Comparator (250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of: * Amoxicillin 3000 mg * Omeprazole 120 mg One 50mg Riboflavin tablet to be taken once daily to maintain the blind.