H PyloriPhase 4NCT07040839
Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection
A Phase 4 study testing Clarithromycin 500 mg, Amoxicillin 1 g and Omeprazole 40 mg in people with H Pylori, run by Rehman Medical Institute - RMI at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- H Pylori
- What is being tested?
- Clarithromycin 500 mg, Amoxicillin 1 g and Omeprazole 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2025to Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients who tested positive on stool antigen
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Efficacy of Omeprazole and Vonoprazan in the Treatment of Helicobacter 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.
Read the 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
- Being tested
- Clarithromycin 500 mg, Amoxicillin 1 g, Omeprazole 40 mg, Vonoprazan 20 mg, Levofloxacin 500 mg
- Keywords
- omeprazole, vonoprazon, proton pump inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin 500 mgDrug
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 gDrug
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Omeprazole 40 mgDrug
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Clarithromycin 500 mgDrug
Clarithromycin 500 mg orally twice daily for 14 days
Amoxicillin 1 gDrug
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mgDrug
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
Levofloxacin 500 mgDrug
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 gDrug
Amoxicillin 1 g orally twice daily for 14 days
Omeprazole 40 mgDrug
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
Levofloxacin 500 mgDrug
Levofloxacin 500 mg orally once daily for 14 days
Amoxicillin 1 gDrug
Amoxicillin 1 g orally twice daily for 14 days
Vonoprazan 20 mgDrug
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| First-Line Therapy with Omeprazole | Experimental | Not described Receives: Drug: Clarithromycin 500 mg; Drug: Amoxicillin 1 g; Drug: Omeprazole 40 mg |
| First-Line Therapy with Vonoprazan | Experimental | Not described Receives: Drug: Clarithromycin 500 mg; Drug: Amoxicillin 1 g; Drug: Vonoprazan 20 mg |
| Second-Line Therapy with Omeprazole | Experimental | Not described Receives: 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. Receives: Drug: Levofloxacin 500 mg; Drug: Amoxicillin 1 g; Drug: Vonoprazan 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori Eradication Rate
Proportion of participants with successful eradication of Helicobacter pylori infection, confirmed by a negative stool antigen test.
Measured: 4-6 weeks after completion of therapy
Secondary outcomes (1)
Incidence of Adverse Events
Number and type of treatment-related adverse effects (e.g., nausea, diarrhea, headache, abdominal discomfort) reported by participants during or after therapy
Measured: During the 6-week treatment and follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for H PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehman Medical Institute - RMI
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wajeeha Qayyum, Rehman Medical Institute - RMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040839
- Sponsor's protocol ID
- RMI/RMI-REC/approval 182
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39131848Du 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.
PubMed 38036941Zhang 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.
PubMed 35810638Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036.
PubMed 32327613Kiyotoki 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.
PubMed 31243237Sun 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.
PubMed 31536675
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Omeprazole and Vonoprazan in the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT07040839
- Acronym / sponsor ID
- RMI/RMI-REC/approval 182
- Conditions
- H Pylori
- Keywords
- omeprazole, vonoprazon, proton pump inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Rehman Medical Institute - RMIUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Levofloxacin 500 mg, Drug: Amoxicillin 1 g, Drug: Vonoprazan 20 mgParticipants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who tested positive on stool antigen
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarithromycin 500 mgClarithromycin 500 mg orally twice daily for 14 days | Drug | First-Line Therapy with Omeprazole |
| Amoxicillin 1 gOmeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks | Drug | First-Line Therapy with Omeprazole |
| Omeprazole 40 mgOmeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks | Drug | First-Line Therapy with Omeprazole |
| Clarithromycin 500 mgClarithromycin 500 mg orally twice daily for 14 days | Drug | First-Line Therapy with Vonoprazan |
| Amoxicillin 1 gAmoxicillin 1 g orally twice daily for 14 days | Drug | First-Line Therapy with Vonoprazan |
| Vonoprazan 20 mgVonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks | Drug | First-Line Therapy with Vonoprazan |
| Levofloxacin 500 mgLevofloxacin 500 mg orally once daily for 14 days | Drug | Second-Line Therapy with Omeprazole |
| Amoxicillin 1 gAmoxicillin 1 g orally twice daily for 14 days | Drug | Second-Line Therapy with Omeprazole |
| Omeprazole 40 mgOmeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks | Drug | Second-Line Therapy with Omeprazole |
| Levofloxacin 500 mgLevofloxacin 500 mg orally once daily for 14 days | Drug | Second-Line Therapy with Vonoprazan |
| Amoxicillin 1 gAmoxicillin 1 g orally twice daily for 14 days | Drug | Second-Line Therapy with Vonoprazan |
| Vonoprazan 20 mgVonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks | Drug | Second-Line Therapy with Vonoprazan |
Primary outcome
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.
1 secondary outcome
Incidence of Adverse Events
Time frame: During the 6-week treatment and follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 39131848Malfertheiner 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.
- Background: PubMed 38036941Du 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.
- Background: PubMed 35810638Zhang 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.
- Background: PubMed 32327613Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036.
- Background: PubMed 31243237Kiyotoki 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.
- Background: PubMed 31536675Sun 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clarithromycin 500 mg, Amoxicillin 1 g and Omeprazole 40 mg in people with H Pylori, run by Rehman Medical Institute - RMI at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taimur khan, FCPS (03305485960 ext. 3638, taimur.khan@rmi.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori Eradication Rate (time frame: 4-6 weeks after completion of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040839, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.