An interventional study of Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days and Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days in Helicobacter Pylori Infection, sponsored by Shandong University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Shandong University · Not applicable, Interventional, and Treatment
The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:
14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.
Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
Drug: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days
Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
Also known as: Vonoprazan, Amoxicillin, Tetracycline, Bismuth, 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
Also known as: Vonoprazan, Amoxicillin, Tetracycline, 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days
Also known as: Vonoprazan, Amoxicillin, Tetracycline, 7 days
Eradication rate
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time frame: Immediately after follow-up check
Rate of adverse reactions
A questionnaire on drug-related adverse reactions needs to be completed after treatment.
Time frame: Immediately after follow-up check
Patient compliance
A questionnaire on the number of missed and overdosed doses of medication needs to be completed after treatment. Good compliance was defined as taking 80%-120% of the pills.
Time frame: Immediately after follow-up check
Plan to share: No
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Shandong University