Vonoprazan
DrugPotassium-competitive acid blocker
NCT Number: NCT05649540
The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Changshu No.1 People's Hospital, Changshu, Jiangsu, China
This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Potassium-competitive acid blocker
Antibiotic for H. pylori eradication
Time frame: four to eight weeks after completion of the medication
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: Within 7 days after completion of therapy
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 was defined as poor when they had taken less than 80% of the total medication
Time frame: baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy
Collect the tongue coating and feces of some patients for flora analysis
Nanjing First Hospital, Nanjing Medical University
Other
Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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