NCT05649540

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Detailed description

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection. Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan	Potassium-competitive acid blocker
DRUG	Amoxicillin	Antibiotic for H. pylori eradication

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-07-06
• Completion: 2024-11-05
• First posted: 2022-12-14
• Last updated: 2024-11-19

Locations

13 sites across 1 country: China