Fu Jen Catholic University Hospital
New Taipei City, 243, Taiwan
NCT Number: NCT05371249
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
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Notify Me20 year and older
All sexes
Interventional
Phase 4
New Taipei City, 243, Taiwan
Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
Other names: VAC-7
Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days
Other names: S-14
Time frame: Assessed at least 6 weeks after the therapy
Assessed by urea breath test
Time frame: After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Self-reported adverse effects by patients through a questionnaire.
Time frame: After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Self-reported compliance by patients through a questionnaire.
Fu Jen Catholic University Hospital
Other
Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
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