Helicobacter InfectionPhase 4NCT07720037
Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial
A Phase 4 study testing 10-day group and 14-day group in people with Helicobacter Infection and Vonoprazan, run by Shandong University.
Trial summary
This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Infection, Vonoprazan, Amoxicillin
- What is being tested?
- 10-day group and 14-day group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years, no restriction on gender
- Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test)
- No prior history of Helicobacter pylori eradication therapy
Who cannot join
- Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc.
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- History of allergy to study medications
- Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment
- Pregnant or breastfeeding women, and subjects who refuse to take contraceptive measures during the trial
- Behaviors that may increase disease risks, such as chronic alcohol abuse and drug addiction
- Subjects who are unable or unwilling to sign the informed consent form
About this study
Official title: Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori
This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.
- Conditions
- Helicobacter Infection, Vonoprazan, Amoxicillin
- Being tested
- 10-day group, 14-day group
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-day groupDrug
vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days
14-day groupDrug
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 10-day group | Experimental | 10-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg tid, amoxicillin (United Laboratories Co., LTD) 1000mg tid Receives: Drug: 10-day group |
| 14-day group | Active comparator | 14-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg bid, amoxicillin (United Laboratories Co., LTD) 1000mg tid Receives: Drug: 14-day group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Measured: immediately after the procedure
Secondary outcomes (2)
Rate of adverse reactions
Measured: immediately after the procedure
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter 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
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720037
- Sponsor's protocol ID
- KYLL-2026-01-003-2
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT07720037
- Acronym / sponsor ID
- KYLL-2026-01-003-2
- Conditions
- Helicobacter Infection, Vonoprazan, Amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 22 Jul 2026 (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 is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-day group | Experimental | Drug: 10-day group10-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg tid, amoxicillin (United Laboratories Co., LTD) 1000mg tid |
| 14-day group | Active comparator | Drug: 14-day group14-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg bid, amoxicillin (United Laboratories Co., LTD) 1000mg tid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 70 years, no restriction on gender
- Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test)
- No prior history of Helicobacter pylori eradication therapy
Key exclusion criteria (8 listed)
- Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc.
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- History of allergy to study medications
- Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment
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 |
|---|---|---|
| 10-day groupvonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days | Drug | 10-day group |
| 14-day groupvonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days | Drug | 14-day group |
Primary outcome
Eradication rates
Time frame: immediately after the procedure
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
2 secondary outcomes
Rate of adverse reactions
Time frame: immediately after the procedure
Patient compliance
Time frame: immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10-day group and 14-day group in people with Helicobacter Infection and Vonoprazan, run by Shandong University.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 rates (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.