NCT07040839

Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Comparative Efficacy of Omeprazole and Vonoprazan in the Treatment of Helicobacter Pylori Infection

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Rehman Medical Institute - RMI · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations. This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.

Detailed description

Currently, there are numerous H. pylori eradication regimens, but opinions vary regarding the effectiveness of those based on P-CAB or PPI. Zhang et al. 4 concluded that the P-CAB-based triple regimen was superior to the PPI-based regimen, whereas Du et al.5 suggested that a vonoprazan and amoxicillin duo regimen may be the preferred first-line option for H. pylori eradication in clinical practice. However, due to limited evidence, the efficacy of various H. pylori eradication regimens using tegoprazan or vonoprazan could not be compared. Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations. This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice. Objective: To compare the efficacy of vonoprazan-based H. pylori eradication therapy with conventional proton pump inhibitors based therapy.

Conditions

• H Pylori

Interventions

Type	Name	Description
DRUG	Clarithromycin 500 mg	Clarithromycin 500 mg orally twice daily for 14 days
DRUG	Amoxicillin 1 g	Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
DRUG	Omeprazole 40 mg	Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
DRUG	Clarithromycin 500 mg	Clarithromycin 500 mg orally twice daily for 14 days
DRUG	Amoxicillin 1 g	Amoxicillin 1 g orally twice daily for 14 days
DRUG	Vonoprazan 20 mg	Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
DRUG	Levofloxacin 500 mg	Levofloxacin 500 mg orally once daily for 14 days
DRUG	Amoxicillin 1 g	Amoxicillin 1 g orally twice daily for 14 days
DRUG	Omeprazole 40 mg	Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
DRUG	Levofloxacin 500 mg	Levofloxacin 500 mg orally once daily for 14 days
DRUG	Amoxicillin 1 g	Amoxicillin 1 g orally twice daily for 14 days
DRUG	Vonoprazan 20 mg	Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Pakistan