Helicobacter Pylori EradicationPhase 4NCT05191888
14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy
A Phase 4 study testing Vonoprazan and Amoxicillin, Vonoprazan, Amoxicillin and Clarithromycin and Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole in people with Helicobacter Pylori Eradication, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
1. Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis. 2. To ensure that the research results are not artificially distorted, this trial is a randomized study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- Vonoprazan and Amoxicillin, Vonoprazan, Amoxicillin and Clarithromycin and Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Aug 2021to 31 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
- Subjects infected with Helicobacter pylori.
Who cannot join
- Those who have ever received Helicobacter pylori sterilization treatment.
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or malignant tumors.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 807
Deng-Chyang Wu, MD,PHD, 886-7-3121101 ext. 7451, dechwu@yahoo.com
About this study
Official title: 14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori
- Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis.
- To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the "random number table generated by a computer similar to the lottery" to determine the treatment group) accept one of the following schemes (1:1:1).
Read the detailed description
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. This study were (1) to test whether the efficacies of 14-day PCAB-based high-dose dual therapy and 14-day PPI-based reverse hybrid therapy can achieve a higher eradication rate than 14-day PCAB-based triple therapy in the first-line treatment of H pylori infection, (2) to compare the eradication rates of 14-day PCAB-based and PPI-based bismuth quadruple therapies in the second-line treatment of H pylori infection, and (3) to examine the impacts of antibiotic resistance of H pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- Vonoprazan and Amoxicillin, Vonoprazan, Amoxicillin and Clarithromycin, Rabeprazole, 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
14-day vonoprazan high-dose two-in-one therapy
Vonoprazan, Amoxicillin and ClarithromycinDrug
14-day vonoprazan triple therapy
Rabeprazole, Amoxicillin, Clarithromycin and MetronidazoleDrug
14th Rabeprazole reverse mixed therapy
| Study group | Role | What they receive |
|---|---|---|
| 14-day vonoprazan high-dose two-in-one therapy | Active comparator | vonoprazan 20mg bid and amoxicillin 750mg qid Receives: Drug: Vonoprazan and Amoxicillin |
| 14-day vonoprazan triple therapy | Active comparator | vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid Receives: Drug: Vonoprazan, Amoxicillin and Clarithromycin |
| 14th Rabeprazole reverse mixed therapy | Active comparator | first 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid Receives: Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of Helicobacter pylori
Evaluate eradication outcome by 13C uear breath test
Measured: 6 week after finishing study drugs
Secondary outcomes (1)
Adverse drug reactions
drugs
Measured: 2weeks after finishing study drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start6 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 EradicationStudies 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
- Model description
- 1. 14-day vonoprazan high-dose two-in-one therapy 2. 14-day vonoprazan triple therapy 3. 14th Rabeprazole reverse mixed therapy
- Masking
- None (open label)
- Enrolment
- 906 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DENG-CHYANG WU, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191888
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210136
- Status last verified
- Jan 2022
- First submitted
- 28 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu PI, Chen CL, Shih CA, Chen KY, Tai WC, Chuah SK, Lee CL, Tsay FW, Yang JC, Lei WY, Kuo CH, Shie CB, Lee HC, Yamaoka Y, Graham DY, Wu DC; Taiwan Acid-related Disease and Microbiota (TARD-M) Consortium. Vonoprazan High-Dose Dual, Vonoprazan Triple, and Rabeprazole Reverse Hybrid Therapies for First-Line Treatment of Helicobacter pylori Infection: A Multicenter Randomized Trial. Am J Gastroenterol. 2025 Jun 16. doi: 10.14309/ajg.0000000000003607. Online ahead of print.
PubMed 40560185
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT05191888
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210136
- Conditions
- Helicobacter Pylori Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 906 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jan 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.
- Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis.
- To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the "random number table generated by a computer similar to the lottery" to determine the treatment group) accept one of the following schemes (1:1:1).
Detailed description
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. This study were (1) to test whether the efficacies of 14-day PCAB-based high-dose dual therapy and 14-day PPI-based reverse hybrid therapy can achieve a higher eradication rate than 14-day PCAB-based triple therapy in the first-line treatment of H pylori infection, (2) to compare the eradication rates of 14-day PCAB-based and PPI-based bismuth quadruple therapies in the second-line treatment of H pylori infection, and (3) to examine the impacts of antibiotic resistance of H pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. 14-day vonoprazan high-dose two-in-one therapy 2. 14-day vonoprazan triple therapy 3. 14th Rabeprazole reverse mixed therapy
| Arm | Type | Receives |
|---|---|---|
| 14-day vonoprazan high-dose two-in-one therapy | Active comparator | Drug: Vonoprazan and Amoxicillinvonoprazan 20mg bid and amoxicillin 750mg qid |
| 14-day vonoprazan triple therapy | Active comparator | Drug: Vonoprazan, Amoxicillin and Clarithromycinvonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid |
| 14th Rabeprazole reverse mixed therapy | Active comparator | Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazolefirst 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects infected with Helicobacter pylori.
Key exclusion criteria (5 listed)
- Those who have ever received Helicobacter pylori sterilization treatment.
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or 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 Amoxicillin14-day vonoprazan high-dose two-in-one therapy | Drug | 14-day vonoprazan high-dose two-in-one therapy |
| Vonoprazan, Amoxicillin and Clarithromycin14-day vonoprazan triple therapy | Drug | 14-day vonoprazan triple therapy |
| Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole14th Rabeprazole reverse mixed therapy | Drug | 14th Rabeprazole reverse mixed therapy |
Primary outcome
the rate of Helicobacter pylori
Time frame: 6 week after finishing study drugs
Evaluate eradication outcome by 13C uear breath test
1 secondary outcome
Adverse drug reactions
Time frame: 2weeks after finishing study drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 40560185Hsu PI, Chen CL, Shih CA, Chen KY, Tai WC, Chuah SK, Lee CL, Tsay FW, Yang JC, Lei WY, Kuo CH, Shie CB, Lee HC, Yamaoka Y, Graham DY, Wu DC; Taiwan Acid-related Disease and Microbiota (TARD-M) Consortium. Vonoprazan High-Dose Dual, Vonoprazan Triple, and Rabeprazole Reverse Hybrid Therapies for First-Line Treatment of Helicobacter pylori Infection: A Multicenter Randomized Trial. Am J Gastroenterol. 2025 Jun 16. doi: 10.14309/ajg.0000000000003607. Online ahead of print.
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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.
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, Vonoprazan, Amoxicillin and Clarithromycin and Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole in people with Helicobacter Pylori Eradication, run by Kaohsiung Medical University 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 5 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 14 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deng-Chyang Wu, MD, PhD (886-7-*3121101 ext. 7451, dechwu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of Helicobacter pylori (time frame: 6 week after finishing study drugs). 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 NCT05191888, 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 14 Jan 2022.