Helicobacter PyloriPhase 4NCT05371249
Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy
A Phase 4 study testing Vonoprazan-based triple therapy and Extended sequential therapy in people with Helicobacter Pylori, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Vonoprazan-based triple therapy and Extended sequential therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 28 Feb 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.
Who cannot join
- Who had received helicobacter pylori eradication before
- Who are known to be allergic to any drug used in this trial
- Pregnant women
- Who are refuse to participate in the trial for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
Read the detailed description
Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.
- Conditions
- Helicobacter Pylori
- Being tested
- Vonoprazan-based triple therapy, Extended sequential therapy
- Keywords
- Proton Pump Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan-based triple therapyDrug
Also called VAC-7
vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
Extended sequential therapyDrug
Also called S-14
Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan-based triple therapy group | Experimental | Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days) Receives: Drug: Vonoprazan-based triple therapy |
| Extended sequential therapy group | Active comparator | Including patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days) Receives: Drug: Extended sequential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of helicobacter pylori
Assessed by urea breath test
Measured: Assessed at least 6 weeks after the therapy
Secondary outcomes (2)
Adverse effects of the drugs
Self-reported adverse effects by patients through a questionnaire.
Measured: After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Compliance
Self-reported compliance by patients through a questionnaire.
Measured: After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Dec 2021
- Primary completion30 Dec 2023
- Study completion28 Feb 2024
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 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
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-tse Chiu, MD, Study chair, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371249
- Sponsor's protocol ID
- FJUH110108
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository and are available on request for the use of academic research in relevant field after the study is published, in the form of excel file with de-identification (main contact: Chiu, Yu-tse, b95401030@gmail.com; consent from participants had been obtained).
Publications
Chiu YT, Lee FJ, Kuo CY, Chen YT, Lin YC, Liang KS, Wu CY, Lin RT, Lin JT, Chang CY. Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13129. doi: 10.1111/hel.13129.
PubMed 39164808
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
- ClinicalTrials.gov ID
- NCT05371249
- Acronym / sponsor ID
- FJUH110108
- Conditions
- Helicobacter Pylori
- Keywords
- Proton Pump Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 12 May 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.
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
Detailed description
Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan-based triple therapy group | Experimental | Drug: Vonoprazan-based triple therapyIncluding patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days) |
| Extended sequential therapy group | Active comparator | Drug: Extended sequential therapyIncluding patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.
Key exclusion criteria (4 listed)
- Who had received helicobacter pylori eradication before
- Who are known to be allergic to any drug used in this trial
- Pregnant women
- Who are refuse to participate in the trial for any reason
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 |
|---|---|---|
| Vonoprazan-based triple therapyAlso: VAC-7vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days | Drug | Vonoprazan-based triple therapy group |
| Extended sequential therapyAlso: S-14Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days | Drug | Extended sequential therapy group |
Primary outcome
Eradication rate of helicobacter pylori
Time frame: Assessed at least 6 weeks after the therapy
Assessed by urea breath test
2 secondary outcomes
Adverse effects of the drugs
Time frame: After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Compliance
Time frame: After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
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 17 Jul 2026.
- Derived from this study: PubMed 39164808Chiu YT, Lee FJ, Kuo CY, Chen YT, Lin YC, Liang KS, Wu CY, Lin RT, Lin JT, Chang CY. Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13129. doi: 10.1111/hel.13129.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository and are available on request for the use of academic research in relevant field after the study is published, in the form of excel file with de-identification (main contact: Chiu, Yu-tse, b95401030@gmail.com; consent from participants had been obtained).
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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.
Yu-tse Chiu, MD study chair
Fu Jen Catholic University Hospital
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 Vonoprazan-based triple therapy and Extended sequential therapy in people with Helicobacter Pylori, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
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 4 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 17 Jul 2026. 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 Taiwan. 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?
Eradication rate of helicobacter pylori (time frame: Assessed at least 6 weeks after the 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 NCT05371249, 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 17 Jul 2026.