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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
556
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
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
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)
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