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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
561
tegoprazan-containing bismuth quadruple therapy or Esomeprazole-containing bismuth quadruple therapy; Route of administration: oral;
Peking University Third Hospital
Beijing, Beijing Municipality, China
Percentage of All Participants With Successful Helicobacter Pylori (H.Pylori) Eradication
Percentage of all patients with Hp eradication determined by a 13\^C-urea breath test after study treatment.
Time frame: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline
Time frame: Day 29+7 days following the completion of treatment( duration of treatment was 2 weeks)
Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-sensitive Strain of H Pylori at Baseline
Time frame: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-resistant Strain of H Pylori at Baseline
Time frame: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-sensitive Strain of H Pylori at Baseline
Time frame: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
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