NCT05577468

Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori

A Multi-center, Randomized, Double-blind, Double-dummy Phase III Clinical Study to Evaluate the Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, double-dummy, phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China. Screening phase: After signing the informed consent form, subjects will be determined for Helicobacter pylori infection by 13\^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 ratio to receive the tegoprazan-containing bismuth quadruple therapy (hereinafter referred to as the tegoprazan group) or esomeprazole-containing bismuth quadruple therapy (hereinafter referred to as the esomeprazole group). Treatment phase: Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days. Follow-up phase: Within 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13\^C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Tegoprazan	tegoprazan-containing bismuth quadruple therapy or Esomeprazole-containing bismuth quadruple therapy; Route of administration: oral;

Timeline

• Start date: 2022-10-30
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-10-13
• Last updated: 2024-01-10

Locations

1 site across 1 country: China