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.

Condition studied

Helicobacter Pylori Infection

Investigational medicinal product(s)

Every trial of Metronidazole across our registers →

Eligibility

Primary endpoint

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.

Endpoint detail

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.