Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection
NCT ID: NCT07040839
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
128 participants
INTERVENTIONAL
2025-07-31
2026-02-28
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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First-Line Therapy with Omeprazole
Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
First-Line Therapy with Vonoprazan
Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Second-Line Therapy with Omeprazole
Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days
Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Second-Line Therapy with Vonoprazan
Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Interventions
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Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days
Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
12 Years
ALL
Yes
Sponsors
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Rehman Medical Institute - RMI
OTHER
Responsible Party
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Wajeeha Qayyum
Consultant/Assistant Professor Medicine
Locations
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Rehman Medical Institue
Peshawar, K, Pakistan
Countries
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Central Contacts
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References
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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.
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.
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.
Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036.
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.
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.
Other Identifiers
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RMI/RMI-REC/approval 182
Identifier Type: -
Identifier Source: org_study_id
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