NCT06412588

Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.

Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 579 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Detailed description

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days	Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.
DRUG	Vonoprazan+Amoxicillin	Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.
DRUG	Vonoprazan+doxycycline	Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.

Timeline

• Start date: 2024-06-15
• Primary completion: 2026-01-01
• Completion: 2026-01-10
• First posted: 2024-05-14
• Last updated: 2026-03-04

Locations

1 site across 1 country: China