The purpose of this study was to evaluate the Efficacy and Safety of Vonoprazan- amoxicillin dual therapy for Helicobacter Pylori eradication
This study intends to select the patients with Hp infection in 11 tertiary hospitals across our country, and randomly give the two therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection. Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
914
Potassium-competitive acid blocker
Antibiotic for H. pylori eradication
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Changshu No.1 People's Hospital
Suzhou, Jiangsu, China
Helicobacter pylori eradication rate
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Time frame: four to six weeks after completion of the medication
Adverse events
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
Time frame: Within 7 days after completion of therapy
Compliance Rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Time frame: Within 7 days after completion of therapy
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Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Taixing People's Hospital
Taizhou, Jiangsu, China
Taizhou Fourth People's Hospital
Taizhou, Jiangsu, China
Wuxi People's Hospital Affiliated to Nanjing Medical University
Wuxi, Jiangsu, China
The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
Xuzhou, Jiangsu, China
Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School
Yancheng, Jiangsu, China
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China