Helicobacter Pylori InfectionPhase 4NCT05614934
Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
A Phase 4 study testing standard Clarithromycin triple therapy, Vonoprazan triple therapy and Vonoprazan dual therapy in people with Helicobacter Pylori Infection, run by Alexandria University at 1 site in Egypt.
Trial summary
Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- standard Clarithromycin triple therapy, Vonoprazan triple therapy and Vonoprazan dual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2022to 15 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with positive stool antigen test result for H. pylori
- Patients recently diagnosed with H. pylori infection and did not receive any treatment
Who cannot join
- Patients sensitive to any of the regimens' components
- Patients who had received a previous eradication therapy and still show positive test results
- Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
- Patients with gastric malignancy or who underwent previous gastric surgery
- Pregnancy and lactation
- Patients with major concomitant diseases, including psychic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.
The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile
Read the detailed description
- Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
- Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
- Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
- Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
- Following up treatment side effects while taking the medications.
- Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
- Assessing patient compliance to different regimens during the final visit.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- standard Clarithromycin triple therapy, Vonoprazan triple therapy, Vonoprazan dual therapy
- Keywords
- Helicobacter Pylori, vonoprazan, standard triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard Clarithromycin triple therapyDrug
Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days
Vonoprazan triple therapyDrug
Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days
Vonoprazan dual therapyDrug
Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| S3 | Active comparator | Standard clarithromycin triple Receives: Drug: standard Clarithromycin triple therapy |
| V3 | Experimental | Vonoprazan triple Receives: Drug: Vonoprazan triple therapy |
| V2 | Experimental | Vonoprazan dual Receives: Drug: Vonoprazan dual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the eradication rates for each regimen
Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis.
Measured: 1.5 month
Secondary outcomes (2)
Determination of number of compliant participants to each regimen
Adherence to therapies is determined through pill count in medication boxes In addition to reviewing a daily medication schedule filled by the participant.
Measured: 1.5 month
Determination of number of participants with treatment related adverse events
Patients will be contacted on a regular basis to monitor any reported adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start11 Jun 2022
- Primary completion1 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Open-labeled, prospective, three-arm, parallel-group, non-placebo Randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yumna Mohamed Shekeban, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614934
- Sponsor's protocol ID
- 0107175
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8.
PubMed 40341536
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
- ClinicalTrials.gov ID
- NCT05614934
- Acronym / sponsor ID
- 0107175
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, vonoprazan, standard triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Jun 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 14 Nov 2022 (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.
Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.
The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile
Detailed description
- Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
- Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
- Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
- Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
- Following up treatment side effects while taking the medications.
- Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
- Assessing patient compliance to different regimens during the final visit.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-labeled, prospective, three-arm, parallel-group, non-placebo Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| S3 | Active comparator | Drug: standard Clarithromycin triple therapyStandard clarithromycin triple |
| V3 | Experimental | Drug: Vonoprazan triple therapyVonoprazan triple |
| V2 | Experimental | Drug: Vonoprazan dual therapyVonoprazan dual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with positive stool antigen test result for H. pylori
- Patients recently diagnosed with H. pylori infection and did not receive any treatment
Key exclusion criteria (6 listed)
- Patients sensitive to any of the regimens' components
- Patients who had received a previous eradication therapy and still show positive test results
- Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
- Patients with gastric malignancy or who underwent previous gastric surgery
- Pregnancy and lactation
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 |
|---|---|---|
| standard Clarithromycin triple therapyOral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days | Drug | S3 |
| Vonoprazan triple therapyOral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days | Drug | V3 |
| Vonoprazan dual therapyOral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days | Drug | V2 |
Primary outcome
Determination of the eradication rates for each regimen
Time frame: 1.5 month
Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis.
2 secondary outcomes
Determination of number of compliant participants to each regimen
Time frame: 1.5 month
Determination of number of participants with treatment related adverse events
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 40341536Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 standard Clarithromycin triple therapy, Vonoprazan triple therapy and Vonoprazan dual therapy in people with Helicobacter Pylori Infection, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 21 Feb 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the eradication rates for each regimen (time frame: 1.5 month). 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 NCT05614934, which also lists 1 linked publication.
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 21 Feb 2025.