Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic UlcerPhase 4NCT07068607
Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
A Phase 4 study testing Vonoprazan, Tetracycline 500mg tid and Minocycline in people with Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer, run by Yongquan Shi at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer
- What is being tested?
- Vonoprazan, Tetracycline 500mg tid and Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Nov 2025
- 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 - 70 years, regardless of gender;
- Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
- For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.
Who cannot join
- Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
- Patients with contraindications to the study drug or who are allergic to the study drug;
- Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening);
- Pregnant and lactating women;
- Patients who have undergone upper gastrointestinal surgery;
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- Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
- Patients with symptoms of dysphagia;
- Patients with evidence of bleeding or iron - deficiency anemia;
- Patients with a history of malignant tumors;
- Patients with a history of drug or alcohol abuse within the past 1 year;
- Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
- Patients with mental disorders;
- Patients who have participated in other clinical trials within the past 3 months;
- Patients who refuse to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032
Yongquan Shi, Ph. D, 86-29-84771515, shiyquan@fmmu.edu.cn
About this study
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
Read the detailed description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.
- Being tested
- Vonoprazan, Tetracycline 500mg tid, Minocycline, Bismuth, Clarithromycin 500 mg
- Medical subject headings
- Gastritis, Dyspepsia, Stomach Neoplasms, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Vonoprazan - amoxicillin dual therapy
Vonoprazan - amoxicillin dual therapy: Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days; Vonoprazan-minocycline dual therapy:Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Tetracycline 500mg tidDrug
Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
MinocyclineDrug
Vonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
BismuthDrug
Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Clarithromycin 500 mgDrug
Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
AmoxicillinDrug
Vonoprazan - amoxicillin dual therapy:Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan - amoxicillin dual therapy | Experimental | Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days Receives: Drug: Vonoprazan; Drug: Amoxicillin |
| Vonoprazan-tetracycline dual therapy | Experimental | Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days Receives: Drug: Vonoprazan; Drug: Tetracycline 500mg tid |
| Vonoprazan-minocycline dual therapy | Experimental | Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days Receives: Drug: Vonoprazan; Drug: Minocycline |
| Bismuth-containing quadruple therapy | Active comparator | Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days Receives: Drug: Vonoprazan; Drug: Bismuth; Drug: Clarithromycin 500 mg; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
The primary end point of this study is H.pylori eradication#established by negative [13C] urea breath test #DOB value below 3.9#28 days after the end of eradication
Measured: 28 days after treatment
Secondary outcomes (1)
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain
Measured: 14 days of treatment, and 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Apr 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (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 Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic UlcerStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongquan Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068607
- Sponsor's protocol ID
- KY20252096-F-1
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Li DH, Guo QQ, Zhang J, Zhu XJ, Liu YH, Zhang YP, Chen M, Shi YQ. Efficacy and Safety of Vonoprazan-Based Dual Therapies With Different Antibiotics Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Prospective, Four-Arm, Randomized Controlled Trial. Helicobacter. 2026 May-Jun;31(3):e70132. doi: 10.1111/hel.70132.
PubMed 42141850
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07068607
- Acronym / sponsor ID
- KY20252096-F-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yongquan ShiUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 16 Jul 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.
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
Detailed description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan - amoxicillin dual therapy | Experimental | Drug: Vonoprazan, Drug: AmoxicillinVonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days |
| Vonoprazan-tetracycline dual therapy | Experimental | Drug: Vonoprazan, Drug: Tetracycline 500mg tidVonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days |
| Vonoprazan-minocycline dual therapy | Experimental | Drug: Vonoprazan, Drug: MinocyclineVonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days |
| Bismuth-containing quadruple therapy | Active comparator | Drug: Vonoprazan, Drug: Bismuth, Drug: Clarithromycin 500 mg, Drug: AmoxicillinAmoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days |
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 - 70 years, regardless of gender;
- Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
- For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.
Key exclusion criteria (15 listed)
- Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
- Patients with contraindications to the study drug or who are allergic to the study drug;
- Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening);
- Pregnant and lactating women;
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 |
|---|---|---|
| VonoprazanAlso: Vonoprazan - amoxicillin dual therapyVonoprazan - amoxicillin dual therapy: Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days; Vonoprazan-minocycline dual therapy:Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days | Drug | Bismuth-containing quadruple therapy, Vonoprazan - amoxicillin dual therapy, Vonoprazan-minocycline dual therapy, Vonoprazan-tetracycline dual therapy |
| Tetracycline 500mg tidVonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days | Drug | Vonoprazan-tetracycline dual therapy |
| MinocyclineVonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days | Drug | Vonoprazan-minocycline dual therapy |
| BismuthBismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days | Drug | Bismuth-containing quadruple therapy |
| Clarithromycin 500 mgBismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days | Drug | Bismuth-containing quadruple therapy |
| AmoxicillinVonoprazan - amoxicillin dual therapy:Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days | Drug | Bismuth-containing quadruple therapy, Vonoprazan - amoxicillin dual therapy |
Primary outcome
Helicobacter pylori eradication
Time frame: 28 days after treatment
The primary end point of this study is H.pylori eradication#established by negative [13C] urea breath test #DOB value below 3.9#28 days after the end of eradication
1 secondary outcome
adverse events
Time frame: 14 days of treatment, and 28 days after treatment
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 14 Aug 2025.
- Derived from this study: PubMed 42141850Li J, Li DH, Guo QQ, Zhang J, Zhu XJ, Liu YH, Zhang YP, Chen M, Shi YQ. Efficacy and Safety of Vonoprazan-Based Dual Therapies With Different Antibiotics Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Prospective, Four-Arm, Randomized Controlled Trial. Helicobacter. 2026 May-Jun;31(3):e70132. doi: 10.1111/hel.70132.
- Individual participant dataSharing planned: No
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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.
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, Tetracycline 500mg tid and Minocycline in people with Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer, run by Yongquan Shi at 1 site in China.
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 15 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: looking for participants now, as of the sponsor's last update on 14 Aug 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 China. 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?
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?
Contact Yongquan Shi, Ph. D (86-29-84771515, shiyquan@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication (time frame: 28 days after treatment). 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 NCT07068607, 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 Aug 2025.