Clinical Research Directory

Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection

Sponsor: Yongquan Shi

Summary

This clinical trial aims to compare the efficacy of the dual therapy regimen of linralase glutarate capsules and amoxicillin versus the quadruple therapy regimen containing bismuth for the first-line eradication of Helicobacter pylori infection. The primary questions this trial aims to address include: 1. Whether the linalarenate glutarate capsule-amoxicillin dual-drug regimen is non-inferior to the bismuth-containing quadruple therapy, while simultaneously evaluating patient adherence and the incidence of adverse events in both treatment groups. Participants will: 1. Treatment group: Linaralate Glutarate Capsules (50 mg bid) + Amoxicillin (1 g tid), for a 14-day treatment course. 2. Control group: Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. The primary endpoint is the Helicobacter pylori eradication rate 4 weeks after discontinuation of treatment.

Official title: Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Controlled Study

Key Details

Conditions

Interventions

Locations (24)