NCT06250634

Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection

Esomeprazole / Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection: a Multi-center, Prospective, Open-label, Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: The Third Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 14 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	esomeprazole + amoxicillin	esomeprazole enteric-coated tablets (AstraZeneca) 20mg four times daily and amoxicillin capsules (Hainan General Sanyang Pharmaceutical) 750mg four times daily
DRUG	esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent	20mg twice daily of esomeprazole enteric-coated tablets, 1000 mg twice daily of amoxicillin capsules, 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical) and 165 mg three times daily of colloidal bismuth tartrate capsules (Shanxi Xinbaoyuan Pharmaceutical)
DRUG	Vonoprazan + amoxicillin	20 mg twice daily of vonoprazan fumarate tablets (Takeda Pharmaceutical Company Limited) and 1000 mg three times daily of amoxicillin capsules (Hainan General Sanyang Pharmaceutical)
DRUG	Vonoprazan + amoxicillin + clarithromycin	20 mg twice daily of vonoprazan fumarate tablets, 1000 mg twice daily of amoxicillin capsules and 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical)

Timeline

• Start date: 2024-02-10
• Primary completion: 2024-05-10
• Completion: 2024-05-10
• First posted: 2024-02-09
• Last updated: 2024-05-29

Locations

1 site across 1 country: China