A Randomized, Multicenter, Single-Blind, Parallel-Group Phase III Non-Inferiority Trial Comparing the Efficacy and Tolerability of a Fixed-Dose Combination of Metronidazole, Bismuth Oxide and Tetracycline HCl to Standard Concomitant Non-Bismuth Quadruple Therapy for First-Line Eradication of Helicobacter pylori in Adults.

Helicobacter Pylori Infection

The primary endpoint is the successful clearance of the infection between the two groups, established by comparing the eradication rate in the microbiological intention-to-treat (mITT) set between the treatment arms. Successful clearance is defined as a negative Urea Breath Test (UBT) following the completion of the eradication treatment.

H. pylori eradication rate in the Per-Protocol (PP) population., Superiority: Statistical comparison of eradication rates (mITT and PP) to test for superiority of the Test arm over the Active Comparator., Compliance: The proportion of patients with adequate adherence (defined as consumption of ≥90% of prescribed units) based on unit counts and diary records., Incidence of Adverse Events (AEs): The proportion of patients reporting at least one AE., Tolerability: The proportion of patients who discontinued treatment prematurely due to AEs.

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