NCT07179159

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Yanqing Li · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Conditions

• HELICOBACTER PYLORI INFECTIONS

Interventions

Type	Name	Description
DRUG	14-day vonoprazan-amoxicillin dual therapy	vonoprazan 20mg bid + amoxicillin 1000mg bid
DRUG	14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy	vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
DRUG	14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy	vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

Timeline

• Start date: 2025-09-09
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2025-09-17
• Last updated: 2026-04-15

Locations

2 sites across 1 country: China