A Phase 4 interventional study of Vonoprazan and Amoxicillin in Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 10 sites in China. Open to participants aged 18 Years to 70 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 multicentra, prospective 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, 200 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.
26 studies on the registry are indexed under cyclopia sequence; 11 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 23 interventional studies indexed under cyclopia sequence.
Browse cyclopia sequence studies →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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Exclusion Criteria:
Drug: Vonoprazan · Drug: Amoxicillin
Drug: Vonoprazan · Drug: Bismuth Potassium Citrate · Drug: Minocycline,Metronidazole
Potassium competitive acid blocker
Antibiotics for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Drug pages: Minocycline · Metronidazole
Antibiotics for H. pylori eradication
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea 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 effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)
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
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amoxicillin · Bismuth · Minocycline · Metronidazole
Shanghai Jiao Tong University School of Medicine →