NCT04907747

Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.

Detailed description

Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising. This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups. Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan	Potassium-competitive acid blocker
DRUG	Esomeprazole	Proton pump inhibitor
DRUG	Colloidal bismuth pectin	Gastric mucosal protective drug with anti-H. pylori effect
DRUG	Amoxicillin	Antibiotic for H. pylori eradication
DRUG	Furazolidone	Antibiotic for H. pylori eradication

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-04-13
• Completion: 2022-04-13
• First posted: 2021-06-01
• Last updated: 2021-06-01

Locations

1 site across 1 country: China