Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

NCT07040839 | Not Yet Recruiting Phase 4

• 1 other identifier: RMI/RMI-REC/approval 182
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

H Pylori

Keywords

omeprazole; vonoprazon; proton pump inhibitors

Outcome Measures

Primary Outcomes (1)

• H. pylori Eradication Rate

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

  4-6 weeks after completion of therapy

Secondary Outcomes (1)

• Incidence of Adverse Events

  During the 6-week treatment and follow-up period

Study Arms (4)

First-Line Therapy with Omeprazole

EXPERIMENTAL

Drug: Clarithromycin 500 mg; Drug: Amoxicillin 1 g; Drug: Omeprazole 40 mg

First-Line Therapy with Vonoprazan

EXPERIMENTAL

Drug: Clarithromycin 500 mg; Drug: Amoxicillin 1 g; Drug: Vonoprazan 20 mg

Second-Line Therapy with Omeprazole

EXPERIMENTAL

Drug: Levofloxacin 500 mg; Drug: Amoxicillin 1 g; Drug: Omeprazole 40 mg

Second-Line Therapy with Vonoprazan

EXPERIMENTAL

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

Drug: Levofloxacin 500 mg; Drug: Amoxicillin 1 g; Drug: Vonoprazan 20 mg

Interventions

Clarithromycin 500 mg DRUG

Clarithromycin 500 mg orally twice daily for 14 days

First-Line Therapy with Omeprazole

Amoxicillin 1 g DRUG

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

First-Line Therapy with Omeprazole

Omeprazole 40 mg DRUG

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

First-Line Therapy with Omeprazole

Vonoprazan 20 mg DRUG

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

First-Line Therapy with Vonoprazan

Levofloxacin 500 mg DRUG

Levofloxacin 500 mg orally once daily for 14 days

Second-Line Therapy with Omeprazole

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who tested positive on stool antigen

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Study Sites (1)

Rehman Medical Institue

Peshawar, K, 092, Pakistan

Location

Related Publications (6)

• Malfertheiner P, Moss SF, Daniele P, Pelletier C, Jacob R, Tremblay G, Hubscher E, Leifke E, Chey WD. Potassium-Competitive Acid Blocker and Proton Pump Inhibitor-Based Regimens for First-Line Helicobacter pylori Eradication: A Network Meta-Analysis. Gastro Hep Adv. 2022 Jun 17;1(5):824-834. doi: 10.1016/j.gastha.2022.06.009. eCollection 2022.

  PMID: 39131848 BACKGROUND

• Du RC, Hu YX, Ouyang Y, Ling LX, Xu JY, Sa R, Liu XS, Hong JB, Zhu Y, Lu NH, Hu Y. Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis. Helicobacter. 2024 Jan-Feb;29(1):e13039. doi: 10.1111/hel.13039. Epub 2023 Nov 30.

  PMID: 38036941 BACKGROUND

• Zhang M, Pang M, Zhang M. Efficacy and safety of potassium-competitive acid blockers versus proton pump inhibitors as Helicobacter pylori eradication therapy: a meta-analysis of randomized clinical trials. Clinics (Sao Paulo). 2022 Jul 7;77:100058. doi: 10.1016/j.clinsp.2022.100058. eCollection 2022.

  PMID: 35810638 BACKGROUND

• Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036.

  PMID: 32327613 BACKGROUND

• Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27.

  PMID: 31243237 BACKGROUND

• Sun Y, Zhang J. Helicobacter pylori recrudescence and its influencing factors. J Cell Mol Med. 2019 Dec;23(12):7919-7925. doi: 10.1111/jcmm.14682. Epub 2019 Sep 19.

  PMID: 31536675 BACKGROUND

MeSH Terms

Interventions

Clarithromycin; Amoxicillin; Omeprazole; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Levofloxacin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Central Study Contacts

Taimur khan, FCPS

CONTACT

03305485960; taimur.khan@rmi.edu.pk

Naseer Ahmed, Associate professor

CONTACT

09291583000; dr.naseerahmed99@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant/Assistant Professor Medicine

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

PA (1)