Overview

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

Status:
Not yet recruiting
Trial end date:
2024-03-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.