Helicobacter Pylori InfectionPhase 4NCT06156085
Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy
A Phase 4 study testing Vonoprazan and Amoxicillin and Lansoprazole, Amoxicillin, Clarithromycin and Metronidazole in people with Helicobacter Pylori Infection, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
Background：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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan and Amoxicillin and Lansoprazole, Amoxicillin, Clarithromycin and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2023to 3 Dec 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 naive H. pylori infection
- Subjects with over 20 years old
Who cannot join
- Younger than 20 years old
- Ever received H. eradication therapy
- ever received total or subtotal gastrectomy in the past
- Severe chronic disease, such as end stage renal disease, liver cirrhosis, incurable malignant tumors
- Women who are pregnant or breastfeeding
- Those who are not suitable to receive study drugs: such as a history of allergies to study drugs or serious side effects, etc.
- Patient with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 mt2
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
Background：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 dual therapy, on the other hand, is another appealing choice with simplicity, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen in Taiwan. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy with high-dose Amoxicillin.
Objectives: To compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy, through a randomized controlled trial.
Read more
Methods: Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited. Those who had received H.pylori eradication before, are known to be allergic to any drug used in this trial, are pregnant, or refuse to participate in the trial for any reason will be excluded. We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin (vonoprazan 20 mg + amoxicillin 1000 mg twice daily for fourteen days) and the other receiving extended sequential therapy (lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg, clarithromycin 500mg, and metronidzole 500mg twice daily for an additional 7 days). Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.
Outcome analysis: The study will be designed as a non-inferiority trial. We anticipate that the two regimens will have comparable efficacy. Besides, we'll also design a questionnaire to evaluate the adverse effects, whether they took the drugs in the right way, and patient's satisfaction of the drug regimen. The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects, better compliance, and better satisfaction.
Read the detailed description
Background：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 dual therapy, on the other hand, is another appealing choice with simplicity, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen in Taiwan. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy with high-dose Amoxicillin.
Objectives: To compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy, through a randomized controlled trial.
Methods: Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited. Those who had received H.pylori eradication before, are known to be allergic to any drug used in this trial, are pregnant, or refuse to participate in the trial for any reason will be excluded. We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin (vonoprazan 20 mg + amoxicillin 1000 mg twice daily for fourteen days) and the other receiving extended sequential therapy (lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg, clarithromycin 500mg, and metronidzole 500mg twice daily for an additional 7 days). Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.
Outcome analysis: The study will be designed as a non-inferiority trial. We anticipate that the two regimens will have comparable efficacy. Besides, we'll also design a questionnaire to evaluate the adverse effects, whether they took the drugs in the right way, and patient's satisfaction of the drug regimen. The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects, better compliance, and better satisfaction.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan and Amoxicillin, Lansoprazole, Amoxicillin, Clarithromycin and Metronidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan and AmoxicillinDrug
vonoprazan 20 mg and amoxicillin 1000 mg b.i.d. PC for 14days
Lansoprazole, Amoxicillin, Clarithromycin and MetronidazoleDrug
lansoprazole 30 mg + amoxicillin 1000 mg b.i.d. AC for 7 days, followed by the same PPI + clarithromycin 500 mg + metronidazole 500 mg b.i.d. AC for 7 days
| Study group | Role | What they receive |
|---|---|---|
| VA14 | Experimental | Vonoprazan-Amoxicillin Dual Therapy for 14days Receives: Drug: Vonoprazan and Amoxicillin |
| S14 | Active comparator | Sequential therapy for 14 days Receives: Drug: Lansoprazole, Amoxicillin, Clarithromycin and Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome is the eradication rate in the first-line treatment
At least 6 weeks after the end of treatment, the carbon 13-breath test will be used to evaluate whether the eradication is successful. The eradication rate in each group will be presented as "%
Measured: Up to 8-12 weeks
Secondary outcomes (1)
The secondary outcomes are the compliance, frequency of adverse events
After eradication treatment, participants will go back to the outpatients clinics to evaluate whether they take all of or > 80% drugs. The investigators will also record any side effect associated with treatment, such as skin rash, dizziness, headache, taste distortion, and etc. The severity grading include "none", "mild", "moderate"
Measured: Up to 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start14 Nov 2023
- Primary completion20 Nov 2024
- Study completion3 Dec 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 Pylori InfectionStudies 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
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Yang Chang, PhD, Study chair, Fu Jen Catholic University Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156085
- Sponsor's protocol ID
- FJUH112288
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma TL, Huang CY, Kuo CY, Sung KY, Chiu YT, Wu PR, Lee FJ, Liang KS, Wu KW, Chen YT, Liou YP, Chang CY. Fourteen-day vonoprazan-based dual therapy with amoxicillin as first-line Helicobacter pylori treatment in comparison with sequential therapy: A randomized controlled trial. J Formos Med Assoc. 2026 May 1:S0929-6646(26)00420-1. doi: 10.1016/j.jfma.2026.04.082. Online ahead of print.
PubMed 42069497
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
- ClinicalTrials.gov ID
- NCT06156085
- Acronym / sponsor ID
- FJUH112288
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 5 Dec 2023 (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.
Background：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 dual therapy, on the other hand, is another appealing choice with simplicity, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen in Taiwan. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy with high-dose Amoxicillin.
Objectives: To compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy, through a randomized controlled trial.
Methods: Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited. Those who had received H.pylori eradication before, are known to be allergic to any drug used in this trial, are pregnant, or refuse to participate in the trial for any reason will be excluded. We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin (vonoprazan 20 mg + amoxicillin 1000 mg twice daily for fourteen days) and the other receiving extended sequential therapy (lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg, clarithromycin 500mg, and metronidzole 500mg twice daily for an additional 7 days). Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.
Outcome analysis: The study will be designed as a non-inferiority trial. We anticipate that the two regimens will have comparable efficacy. Besides, we'll also design a questionnaire to evaluate the adverse effects, whether they took the drugs in the right way, and patient's satisfaction of the drug regimen. The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects, better compliance, and better satisfaction.
Detailed description
Background：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 dual therapy, on the other hand, is another appealing choice with simplicity, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen in Taiwan. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy with high-dose Amoxicillin.
Objectives: To compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy, through a randomized controlled trial.
Methods: Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited. Those who had received H.pylori eradication before, are known to be allergic to any drug used in this trial, are pregnant, or refuse to participate in the trial for any reason will be excluded. We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin (vonoprazan 20 mg + amoxicillin 1000 mg twice daily for fourteen days) and the other receiving extended sequential therapy (lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg, clarithromycin 500mg, and metronidzole 500mg twice daily for an additional 7 days). Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.
Outcome analysis: The study will be designed as a non-inferiority trial. We anticipate that the two regimens will have comparable efficacy. Besides, we'll also design a questionnaire to evaluate the adverse effects, whether they took the drugs in the right way, and patient's satisfaction of the drug regimen. The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects, better compliance, and better satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA14 | Experimental | Drug: Vonoprazan and AmoxicillinVonoprazan-Amoxicillin Dual Therapy for 14days |
| S14 | Active comparator | Drug: Lansoprazole, Amoxicillin, Clarithromycin and MetronidazoleSequential therapy for 14 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with naive H. pylori infection
- Subjects with over 20 years old
Key exclusion criteria (7 listed)
- Younger than 20 years old
- Ever received H. eradication therapy
- ever received total or subtotal gastrectomy in the past
- Severe chronic disease, such as end stage renal disease, liver cirrhosis, incurable malignant tumors
- Women who are pregnant or breastfeeding
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 and Amoxicillinvonoprazan 20 mg and amoxicillin 1000 mg b.i.d. PC for 14days | Drug | VA14 |
| Lansoprazole, Amoxicillin, Clarithromycin and Metronidazolelansoprazole 30 mg + amoxicillin 1000 mg b.i.d. AC for 7 days, followed by the same PPI + clarithromycin 500 mg + metronidazole 500 mg b.i.d. AC for 7 days | Drug | S14 |
Primary outcome
primary outcome is the eradication rate in the first-line treatment
Time frame: Up to 8-12 weeks
At least 6 weeks after the end of treatment, the carbon 13-breath test will be used to evaluate whether the eradication is successful. The eradication rate in each group will be presented as "%
1 secondary outcome
The secondary outcomes are the compliance, frequency of adverse events
Time frame: Up to 8-12 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 17 Feb 2026.
- Derived from this study: PubMed 42069497Ma TL, Huang CY, Kuo CY, Sung KY, Chiu YT, Wu PR, Lee FJ, Liang KS, Wu KW, Chen YT, Liou YP, Chang CY. Fourteen-day vonoprazan-based dual therapy with amoxicillin as first-line Helicobacter pylori treatment in comparison with sequential therapy: A randomized controlled trial. J Formos Med Assoc. 2026 May 1:S0929-6646(26)00420-1. doi: 10.1016/j.jfma.2026.04.082. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
Chi-Yang Chang, PhD study chair
Fu Jen Catholic University Hospital, Taiwan
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 and Amoxicillin and Lansoprazole, Amoxicillin, Clarithromycin and Metronidazole in people with Helicobacter Pylori Infection, 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 2 inclusion and 7 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 Feb 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?
primary outcome is the eradication rate in the first-line treatment (time frame: Up to 8-12 weeks). 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 NCT06156085, 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 Feb 2026.