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

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.

Timeline

Start

2022-10-30

Primary completion

2023-09-30

Completion

2023-09-30

Publications

• Song Z, Wang W, Li P, Zuo X, Zhu Y, Chen Y, Zhang X, Lyu B, Lin R, Du Y, Lan C, Wu H, Chen W, Ye Y, Fan H, Liao A, Chen H, Liu C, Zhang Z, Wang W, Suo Z, Li X, Du Q, Li X, Pan F, Tang J, Xu M, Liu X, Zheng P, Chen H, Du L, Lu J, Feng C, Pan W, Wang H, Zeng Z, Wang J, Lyu S, Liu D, Yang S, Li L, Zhou L. Tegoprazan-based versus esomeprazole-based triple therapy plus bismuth for first-line Helicobacter pylori eradication: A nationwide, multicenter, double-blind, double-dummy, randomized controlled trial. Chin Med J (Engl). 2025 Aug 22. doi: 10.1097/CM9.0000000000003780. Online ahead of print.

Drugs

Indications