NCT05371249

Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Fu Jen Catholic University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Vonoprazan-based triple therapy	vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
DRUG	Extended sequential therapy	Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-30
• Completion: 2024-02-28
• First posted: 2022-05-12
• Last updated: 2023-08-07

Locations

1 site across 1 country: Taiwan