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NCT Number: NCT07040839

Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

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.

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Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rehman Medical Institue

Peshawar, K, 092, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clarithromycin 500 mg

Drug

Clarithromycin 500 mg orally twice daily for 14 days

Amoxicillin 1 g

Drug

Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks

Omeprazole 40 MG

Drug

Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks

Vonoprazan 20 mg

Drug

Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks

Levofloxacin 500 mg

Drug

Levofloxacin 500 mg orally once daily for 14 days

Primary outcomes

  1. H. pylori Eradication Rate

    Time frame: 4-6 weeks after completion of therapy

    Proportion of participants with successful eradication of Helicobacter pylori infection, confirmed by a negative stool antigen test.

Secondary outcomes

  1. Incidence of Adverse Events

    Time frame: During the 6-week treatment and follow-up period

    Number and type of treatment-related adverse effects (e.g., nausea, diarrhea, headache, abdominal discomfort) reported by participants during or after therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Naseer Ahmed, Associate professor

CONTACT

[email protected]

09291583000 ext. 4743

Taimur khan, FCPS

CONTACT

[email protected]

03305485960 ext. 3638

Sponsors and collaborators

Lead sponsor

Rehman Medical Institute - RMI

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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