A Phase 4 interventional study of vonoprazan and Amoxicillin in Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 370 studies on the registry; 107 are open to participants now.
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Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc
Drug: vonoprazan · Drug: Amoxicillin
Vonoprazan 20mg bid ac and amoxicillin 1g tid pc
Drug: vonoprazan · Drug: Amoxicillin
Vonoprazan 20mg bid ac and amoxicillin 1g tid ac
Drug: vonoprazan · Drug: Amoxicillin
Potassium competitive acid blocker
Antibiotics for H. pylori eradication
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
Time frame: Six weeks after completion of therapy
Rate of adverse events
The subjects were asked to record side effects and discomfort during treatment and actual drug administration.
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
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vonoprazan · Amoxicillin
Shanghai Jiao Tong University School of Medicine →