A Phase 4 interventional study of 10-day group and 14-day group in Helicobacter Infection, Vonoprazan and Amoxicillin, sponsored by Shandong University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.
Exclusion Criteria:
10-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg tid, amoxicillin (United Laboratories Co., LTD) 1000mg tid
Drug: 10-day group
14-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg bid, amoxicillin (United Laboratories Co., LTD) 1000mg tid
Drug: 14-day group
vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Eradication rates
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time frame: immediately after the procedure
Rate of adverse reactions
Time frame: immediately after the procedure
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Time frame: immediately after the procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shandong University