Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Rehman Medical Institute - RMI

Status and phase: Not yet enrolling; Phase 4

Conditions: H Pylori

Treatments: Drug: Clarithromycin 500 mg; Drug: Levofloxacin 500 mg; Drug: Vonoprazan 20 mg; Drug: Omeprazole 40 mg; Drug: Amoxicillin 1 g

Study type: Interventional

Funder types: Other

Identifiers

NCT07040839

RMI/RMI-REC/approval 182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All patients who tested positive on stool antigen

Exclusion criteria

• patients under 12 years old.
• Patients who have penicillin allergy.
• Patients who have underlying dysrhythmia forbidding the use of macrolide -. Patient who have hypersensitivity to any of these antibiotics or proton pump inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

First-Line Therapy with Omeprazole

Experimental group

Treatment:

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

Drug: Omeprazole 40 mg

Drug: Clarithromycin 500 mg

Drug: Omeprazole 40 mg

Drug: Clarithromycin 500 mg

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

First-Line Therapy with Vonoprazan

Experimental group

Treatment:

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

Drug: Vonoprazan 20 mg

Drug: Clarithromycin 500 mg

Drug: Vonoprazan 20 mg

Drug: Clarithromycin 500 mg

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

Second-Line Therapy with Omeprazole

Experimental group

Treatment:

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

Drug: Omeprazole 40 mg

Drug: Omeprazole 40 mg

Drug: Levofloxacin 500 mg

Drug: Levofloxacin 500 mg

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

Second-Line Therapy with Vonoprazan

Experimental group

Description:

Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.

Treatment:

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g

Drug: Vonoprazan 20 mg

Drug: Vonoprazan 20 mg

Drug: Levofloxacin 500 mg

Drug: Levofloxacin 500 mg

Drug: Amoxicillin 1 g

Drug: Amoxicillin 1 g