HELICOBACTER PYLORI INFECTIONSPhase 3HelicobacterNCT06811207
Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication
A Phase 3 study testing Vonoprazan, Esomeprazole 40mg and Amoxicillin in people with HELICOBACTER PYLORI INFECTIONS, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: The key factors for success are the maintenance of intragastric pH > 6 and the drug resistance to antibiotics. Proton pump inhibitor (PPI)-based high-dose dual therapy is a novel anti-Helicobacter pylori (H. pylori) treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Vonoprazan, Esomeprazole 40mg and Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2025to 28 Feb 2025
- Phase
- Phase 3
- 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
- 1. At least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis are prospectively recruited for this pilot study
Who cannot join
- Previous H. pylori-eradication therapy,
- Ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks,
- Patients with an allergic history to the medications used,
- Patients with previous gastric surgery,
- The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Others, 833
About this study
Background:
The key factors for success are the maintenance of intragastric pH > 6 and the drug resistance to antibiotics. Proton pump inhibitor (PPI)-based high-dose dual therapy is a novel anti-Helicobacter pylori (H. pylori) treatment. According to the investigators' previous study, the Esomeprazole-based high-dose dual therapy can achieve a higher eradication rate than standard triple therapy. The main reason for the high eradication rate was the use of high-dose esomeprazole which maintained 24-hour high intra-gastric pH. Another important reason was that investigators used only one antibiotic (Amoxicillin) with very low antibiotic resistance rates (0-2%). As compared to quadruple concomitant therapy which uses 3 antibiotics (clarithromycin, amoxicillin, and metronidazole), concomitant therapy could induce drug resistance which could affect public health issues.
Read more
Vonoprazan is a new gastric acid suppression agent, classified as a potassium-competitive acid blocker (PCAB). Its acid inhibition efficacy is superior to that of PPI. It has been evidenced that 7-day vonoprazan-based triple therapy achieved a higher eradication rate than 7-day PPI-based triple therapy in the first-line treatment of H. pylori infection but vonoprazan-based high-dose dual therapy can achieve a higher eradication rate than PPI-based thigh-dose dual therapy remains unclear.
Aims: (1) To test whether the efficacies of 14-day PCAB-based high-dose dual therapy can achieve a higher eradication rate than 14-day PPI-based high-dose dual therapy in the first-line treatment of H. pylori infection, (2) to examine the impacts of antibiotic resistance of H. pylori on the eradication efficacies of these two high-dose dual anti- H. pylori treatments.
Methods: The investigators will recruit 300 adult participants with H. pylori infection from Kaohsiung Chang Gung Memorial Hospital. Using a computer-generated randomized sequence, the investigators randomly allocated 150 patients to either 14-day high-dose dual therapy (vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days) or 150 patients (Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days). Participants are asked to return in the second week to assess drug compliance and adverse events. Post-treatment H. pylori status is assessed by a 13C-urea breath test at week 8. Additionally, antibiotic susceptibility of H. pylori will be examined. Finally, the rates of eradication, adverse events and compliance will be compared between two groups by chi-square test, and the host and bacterial factors influencing each efficacy of the regimen are assessed by multivariate analysis.
Expected results: The acid inhibition efficacy of PCAB is superior to that of PPI. The investigators expect the PCAB-based high-dose dual therapy can achieve a better H. pylori eradication rate the PPA-based high-dose dual therapy. Minor adverse effects can be expected in each group of participants.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Vonoprazan, Esomeprazole 40mg, Amoxicillin
- Keywords
- Helicobacter pylori, Potassium-competitive acid blocker, Proton pump inhibitors, High-dose dual therapy, Antibiotic susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Vonoprazan (20 mg bid, for 14 days)
Esomeprazole 40mgDrug
Esomeprazole (40 mg tid, for 14 days)
AmoxicillinDrug
Amoxicillin (750 mg qid, for 14 days)
| Study group | Role | What they receive |
|---|---|---|
| 14-day PCAB-based high-dose dual therapy. | Active comparator | vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days Receives: Drug: Vonoprazan; Drug: Amoxicillin |
| 14-day PPI-Based High-Dose Dual Therapies | Experimental | Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days Receives: Drug: Esomeprazole 40mg; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Eradication of H. pylori Confirmed by Urea Breath Test (UBT)
- Description: This outcome will measure the percentage of participants in each treatment group (PCAB-based dual therapy and PPI-based dual therapy) who achieve H. pylori eradication.
- Definition of Eradication: Eradication is defined as a negative result on the Urea Breath Test (UBT).
- Calculation Method: The proportion of eradicated participants will be calculated as: (Number of participants with confirmed eradication by UBT) / (Total participants analyzed)×100%
Measured: 6 to 8 weeks after the completion of the 14-day treatment period.
Secondary outcomes (1)
Association Between Antibiotic Resistance and H. pylori Eradication Rate
- Description: This outcome will evaluate whether pre-treatment antibiotic resistance (e.g., amoxicillin resistance) is associated with the eradication success rate of PCAB-based and PPI-based high-dose dual therapies.
- Statistical Analysis: The correlation between antibiotic resistance status (resistant vs. susceptible) and eradication outcome (eradicated vs. not eradicated) will be analyzed using appropriate logistic regression models or chi-square tests.
Measured: esistance testing at baseline, and eradication confirmation at 6 to 8 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will recruit 300 adult participants with H. pylori infection from Kaohsiung Chang Gung Memorial Hospital. Using a computer-generated randomized sequence, we randomly allocated 150 patients to either 14-day high-dose dual therapy (vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days) or 150 participants (Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days). Participants are asked to return in the second week to assess drug compliance and adverse events. Post-treatment H. pylori status is assessed by a 13C-urea breath test at week 8. Additionally, antibiotic susceptibility of H. pylori will be examined. Finally, the rates of eradication, adverse events, and compliance will be compared between two groups by chi-square test, and the host and bacterial factors influencing each efficacy of the regimen are assessed by multivariate analysis.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811207
- Sponsor's protocol ID
- IRB 202200416A3
- Other IDs
- CMRPG8M1121
- Acronym
- Helicobacter
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) from this study. The data include sensitive information that may compromise participant privacy, even if de-identified. Ethical considerations and privacy regulations prevent data sharing.
Publications
Liu L, Shi H, Shi Y, Wang A, Guo N, Li F, Nahata MC. Vonoprazan-based therapies versus PPI-based therapies in patients with H. pylori infection: Systematic review and meta-analyses of randomized controlled trials. Helicobacter. 2024 May-Jun;29(3):e13094. doi: 10.1111/hel.13094.
PubMed 38790090Gotoda T, Kusano C, Suzuki S, Horii T, Ichijima R, Ikehara H. Clinical impact of vonoprazan-based dual therapy with amoxicillin for H. pylori infection in a treatment-naive cohort of junior high school students in Japan. J Gastroenterol. 2020 Oct;55(10):969-976. doi: 10.1007/s00535-020-01709-4. Epub 2020 Jul 14.
PubMed 32666199Tai WC, Lu LS, Yang SC, Wang HM, Wu CK, Yao CC, Huang PY, Lee YC, Chuah SK, Liang CM. Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line Helicobacter pylori eradication: a randomized controlled trial. Ther Adv Gastroenterol. 2025 Sep 20;18:17562848251378066. doi: 10.1177/17562848251378066. eCollection 2025.
PubMed 40984972
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT06811207
- Acronym / sponsor ID
- Helicobacter / IRB 202200416A3
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori, Potassium-competitive acid blocker, Proton pump inhibitors, High-dose dual therapy, Antibiotic susceptibility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 6 Feb 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.
Background:
The key factors for success are the maintenance of intragastric pH > 6 and the drug resistance to antibiotics. Proton pump inhibitor (PPI)-based high-dose dual therapy is a novel anti-Helicobacter pylori (H. pylori) treatment. According to the investigators' previous study, the Esomeprazole-based high-dose dual therapy can achieve a higher eradication rate than standard triple therapy. The main reason for the high eradication rate was the use of high-dose esomeprazole which maintained 24-hour high intra-gastric pH. Another important reason was that investigators used only one antibiotic (Amoxicillin) with very low antibiotic resistance rates (0-2%). As compared to quadruple concomitant therapy which uses 3 antibiotics (clarithromycin, amoxicillin, and metronidazole), concomitant therapy could induce drug resistance which could affect public health issues.
Vonoprazan is a new gastric acid suppression agent, classified as a potassium-competitive acid blocker (PCAB). Its acid inhibition efficacy is superior to that of PPI. It has been evidenced that 7-day vonoprazan-based triple therapy achieved a higher eradication rate than 7-day PPI-based triple therapy in the first-line treatment of H. pylori infection but vonoprazan-based high-dose dual therapy can achieve a higher eradication rate than PPI-based thigh-dose dual therapy remains unclear.
Aims: (1) To test whether the efficacies of 14-day PCAB-based high-dose dual therapy can achieve a higher eradication rate than 14-day PPI-based high-dose dual therapy in the first-line treatment of H. pylori infection, (2) to examine the impacts of antibiotic resistance of H. pylori on the eradication efficacies of these two high-dose dual anti- H. pylori treatments.
Methods: The investigators will recruit 300 adult participants with H. pylori infection from Kaohsiung Chang Gung Memorial Hospital. Using a computer-generated randomized sequence, the investigators randomly allocated 150 patients to either 14-day high-dose dual therapy (vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days) or 150 patients (Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days). Participants are asked to return in the second week to assess drug compliance and adverse events. Post-treatment H. pylori status is assessed by a 13C-urea breath test at week 8. Additionally, antibiotic susceptibility of H. pylori will be examined. Finally, the rates of eradication, adverse events and compliance will be compared between two groups by chi-square test, and the host and bacterial factors influencing each efficacy of the regimen are assessed by multivariate analysis.
Expected results: The acid inhibition efficacy of PCAB is superior to that of PPI. The investigators expect the PCAB-based high-dose dual therapy can achieve a better H. pylori eradication rate the PPA-based high-dose dual therapy. Minor adverse effects can be expected in each group of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will recruit 300 adult participants with H. pylori infection from Kaohsiung Chang Gung Memorial Hospital. Using a computer-generated randomized sequence, we randomly allocated 150 patients to either 14-day high-dose dual therapy (vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days) or 150 participants (Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days). Participants are asked to return in the second week to assess drug compliance and adverse events. Post-treatment H. pylori status is assessed by a 13C-urea breath test at week 8. Additionally, antibiotic susceptibility of H. pylori will be examined. Finally, the rates of eradication, adverse events, and compliance will be compared between two groups by chi-square test, and the host and bacterial factors influencing each efficacy of the regimen are assessed by multivariate analysis.
| Arm | Type | Receives |
|---|---|---|
| 14-day PCAB-based high-dose dual therapy. | Active comparator | Drug: Vonoprazan, Drug: Amoxicillinvonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days |
| 14-day PPI-Based High-Dose Dual Therapies | Experimental | Drug: Esomeprazole 40mg, Drug: AmoxicillinEsomeprezole 40 mg tid, and amoxicillin 750mg qid. 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 (1 listed)
- 1. At least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis are prospectively recruited for this pilot study
Key exclusion criteria (6 listed)
- Previous H. pylori-eradication therapy,
- Ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks,
- Patients with an allergic history to the medications used,
- Patients with previous gastric surgery,
- The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
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 |
|---|---|---|
| VonoprazanVonoprazan (20 mg bid, for 14 days) | Drug | 14-day PCAB-based high-dose dual therapy. |
| Esomeprazole 40mgEsomeprazole (40 mg tid, for 14 days) | Drug | 14-day PPI-Based High-Dose Dual Therapies |
| AmoxicillinAmoxicillin (750 mg qid, for 14 days) | Drug | 14-day PCAB-based high-dose dual therapy., 14-day PPI-Based High-Dose Dual Therapies |
Primary outcome
Proportion of Participants With Eradication of H. pylori Confirmed by Urea Breath Test (UBT)
Time frame: 6 to 8 weeks after the completion of the 14-day treatment period.
1. Description: This outcome will measure the percentage of participants in each treatment group (PCAB-based dual therapy and PPI-based dual therapy) who achieve H. pylori eradication. 2. Definition of Eradication: Eradication is defined as a negative result on the Urea Breath Test (UBT). 3. Calculation Method: The proportion of eradicated participants will be calculated as: (Number of participants with confirmed eradication by UBT) / (Total participants analyzed)×100%
1 secondary outcome
Association Between Antibiotic Resistance and H. pylori Eradication Rate
Time frame: esistance testing at baseline, and eradication confirmation at 6 to 8 weeks post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 38790090Liu L, Shi H, Shi Y, Wang A, Guo N, Li F, Nahata MC. Vonoprazan-based therapies versus PPI-based therapies in patients with H. pylori infection: Systematic review and meta-analyses of randomized controlled trials. Helicobacter. 2024 May-Jun;29(3):e13094. doi: 10.1111/hel.13094.
- Background: PubMed 32666199Gotoda T, Kusano C, Suzuki S, Horii T, Ichijima R, Ikehara H. Clinical impact of vonoprazan-based dual therapy with amoxicillin for H. pylori infection in a treatment-naive cohort of junior high school students in Japan. J Gastroenterol. 2020 Oct;55(10):969-976. doi: 10.1007/s00535-020-01709-4. Epub 2020 Jul 14.
- Derived from this study: PubMed 40984972Tai WC, Lu LS, Yang SC, Wang HM, Wu CK, Yao CC, Huang PY, Lee YC, Chuah SK, Liang CM. Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line Helicobacter pylori eradication: a randomized controlled trial. Ther Adv Gastroenterol. 2025 Sep 20;18:17562848251378066. doi: 10.1177/17562848251378066. eCollection 2025.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) from this study. The data include sensitive information that may compromise participant privacy, even if de-identified. Ethical considerations and privacy regulations prevent data sharing.
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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 3 study testing Vonoprazan, Esomeprazole 40mg and Amoxicillin in people with HELICOBACTER PYLORI INFECTIONS, run by Chang Gung Memorial 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 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: status not confirmed, as of the sponsor's last update on 12 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Proportion of Participants With Eradication of H. pylori Confirmed by Urea Breath Test (UBT) (time frame: 6 to 8 weeks after the completion of the 14-day treatment period.). 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 NCT06811207, which also lists 3 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 12 Feb 2025.