A Phase 3 interventional study of Anaprazole Sodium enteric-coated tablet and Esomeprazole magnesium enteric-coated tablets in HELICOBACTER PYLORI INFECTIONS, sponsored by Xuanzhu Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Xuanzhu Biopharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole versus Esomeprazole-containing Bismuth quadruple therapy for eradication of Helicobacter pylori in China.
Exclusion Criteria:
Anaprazole sodium enteric-coated tablets + Esomeprazole magnesium enteric-coated tablets placebo +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets
Drug: Anaprazole Sodium enteric-coated tablet
Anaprazole sodium enteric-coated tablets placebo + Esomeprazole magnesium enteric-coated tablets +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets
Drug: Esomeprazole magnesium enteric-coated tablets
Anaprazole sodium enteric-coated tablets 20mg + Esomeprazole magnesium enteric-coated tablets placebo 1 tablet +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days
Anaprazole sodium enteric-coated tablets placebo 1 tablet + Esomeprazole magnesium enteric-coated tablets20mg +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days
Percentage of all participants with successful Helicobacter Pylori (Hp) eradication
Percentage of all patients with Hp eradication determined by a 13\^C-urea breath test after study treatment
Time frame: Day 28+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 Clarithromycin-resistant strain and Clarithromycin-sensitive strain of H.Pylori at baseline
Time frame: Day 28+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 Amoxicillin-resistant strain and Amoxicillin-sensitive strain of H.Pylori at baseline
Time frame: Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)
Number of Subjects With Adverse Events (AEs)
Time frame: Day 15+3 days following the completion of treatment(duration of treatment was 2 weeks)
AUC0-t
Time frame: Up to 14 days from the start of administration
AUC0-∞
Time frame: Up to 14 days from the start of administration
Cmax
Time frame: Up to 14 days from the start of administration
Tmax
Time frame: Up to 14 days from the start of administration
t½
Time frame: Up to 14 days from the start of administration
CL/F
Time frame: Up to 14 days from the start of administration
Vz/F
Time frame: Up to 14 days from the start of administration
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Xuanzhu Biopharmaceutical Co., Ltd.