the Eradication Rates of Helicobacter PyloriPhase 4NCT06168214
Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication
A Phase 4 study testing Rabeprazloe+bismuth+amoxicillin+clarithromycin, Vonoprazan+amoxicillin+clarithromycin 14 days and Vonoprazan+amoxicillin+clarithromycin 7 days in people with the Eradication Rates of Helicobacter Pylori, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are: Main indicators: the eradication rate of Helicobacter pylori for eradication. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- the Eradication Rates of Helicobacter Pylori
- What is being tested?
- Rabeprazloe+bismuth+amoxicillin+clarithromycin, Vonoprazan+amoxicillin+clarithromycin 14 days and Vonoprazan+amoxicillin+clarithromycin 7 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,404 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2023to 25 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.
Who cannot join
- Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ying han
Xi'an, Shaanxi, 710032
Ying Han, +86-29-84771539, hanying1@fmmu.edu.cn
About this study
Official title: Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.
The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:
- Main indicators: the eradication rate of Helicobacter pylori for eradication.
- Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.
- Being tested
- Rabeprazloe+bismuth+amoxicillin+clarithromycin, Vonoprazan+amoxicillin+clarithromycin 14 days, Vonoprazan+amoxicillin+clarithromycin 7 days, Vonoprazan+tetracycline+furazolidone 14 days, Vonoprazan+tetracycline+furazolidone 7 days
- Keywords
- Helicobacter pylori ; Vonoprazan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazloe+bismuth+amoxicillin+clarithromycinDrug
PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Vonoprazan+amoxicillin+clarithromycin 14 daysDrug
VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Vonoprazan+amoxicillin+clarithromycin 7 daysDrug
VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Vonoprazan+tetracycline+furazolidone 14 daysDrug
VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Vonoprazan+tetracycline+furazolidone 7 daysDrug
VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Vonoprazan+amoxicillin+furazolidone 7 daysDrug
hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
Vonoprazan+amoxicillin+tetracycline 14 daysDrug
hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
Vonoprazan+amoxicillin 7 daysDrug
hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Vonoprazan+amoxicillin 14 daysDrug
hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
| Study group | Role | What they receive |
|---|---|---|
| Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days | Active comparator | 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. Receives: Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin |
| Vonoprazan+amoxicillin+clarithromycin 14 days | Experimental | 14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. Receives: Drug: Vonoprazan+amoxicillin+clarithromycin 14 days |
| Vonoprazan+amoxicillin+clarithromycin 7 days | Experimental | 7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. Receives: Drug: Vonoprazan+amoxicillin+clarithromycin 7 days |
| Vonoprazan+tetracycline+furazolidone 14 days | Experimental | 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. Receives: Drug: Vonoprazan+tetracycline+furazolidone 14 days |
| Vonoprazan+tetracycline+furazolidone 7 days | Experimental | 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. Receives: Drug: Vonoprazan+tetracycline+furazolidone 7 days |
| Vonoprazan+amoxicillin+furazolidone 7 days | Experimental | 7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid. Receives: Drug: Vonoprazan+amoxicillin+furazolidone 7 days |
| Vonoprazan+amoxicillin+tetracycline 14 days | Experimental | 7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid. Receives: Drug: Vonoprazan+amoxicillin+tetracycline 14 days |
| Vonoprazan+amoxicillin 7 days | Experimental | 7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. Receives: Drug: Vonoprazan+amoxicillin 7 days |
| Vonoprazan+amoxicillin 14 days | Experimental | 14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. Receives: Drug: Vonoprazan+amoxicillin 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori
Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).
Measured: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Secondary outcomes (3)
Incidence of adverse effects
According to the requirements of the "Drug Clinical Trial Management Code", the observation is carried out, and the adverse reactions of the patients during the administration of the drug are recorded. The severity, or intensity, of an AE refers to the extent to which an AE affects the subject' s daily activities. The intensity of the AE will be rated as mild (discomfort without influencing daily activities), moderate (discomfort partially influencing daily activities), or severe (discomfort with severe interruption with daily activities).
Measured: 14 days of treatment, and 28 days after treatment
Treatment compliance
Adherence was analysed according to medication possession ratio (MPR), where taking less than 80% of study drug during any evaluation period or failure to review was considered poor adherence;
Measured: 7 or 14 days of treatment
Symptom relief rate
Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms.
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 posted13 Dec 2023
- Study start4 Sep 2023
- Primary completion25 Nov 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Eradication Rates of Helicobacter PyloriStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Ying, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168214
- Sponsor's protocol ID
- XJLL-KY-20230499
- Status last verified
- Aug 2024
- First submitted
- 24 Nov 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06168214
- Acronym / sponsor ID
- XJLL-KY-20230499
- Keywords
- Helicobacter pylori ; Vonoprazan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,404 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 13 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.
The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:
- Main indicators: the eradication rate of Helicobacter pylori for eradication.
- Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days | Active comparator | Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
| Vonoprazan+amoxicillin+clarithromycin 14 days | Experimental | Drug: Vonoprazan+amoxicillin+clarithromycin 14 days14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
| Vonoprazan+amoxicillin+clarithromycin 7 days | Experimental | Drug: Vonoprazan+amoxicillin+clarithromycin 7 days7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
| Vonoprazan+tetracycline+furazolidone 14 days | Experimental | Drug: Vonoprazan+tetracycline+furazolidone 14 days14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. |
| Vonoprazan+tetracycline+furazolidone 7 days | Experimental | Drug: Vonoprazan+tetracycline+furazolidone 7 days7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. |
| Vonoprazan+amoxicillin+furazolidone 7 days | Experimental | Drug: Vonoprazan+amoxicillin+furazolidone 7 days7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid. |
| Vonoprazan+amoxicillin+tetracycline 14 days | Experimental | Drug: Vonoprazan+amoxicillin+tetracycline 14 days7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid. |
| Vonoprazan+amoxicillin 7 days | Experimental | Drug: Vonoprazan+amoxicillin 7 days7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. |
| Vonoprazan+amoxicillin 14 days | Experimental | Drug: Vonoprazan+amoxicillin 14 days14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.
Key exclusion criteria (1 listed)
- Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
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 |
|---|---|---|
| Rabeprazloe+bismuth+amoxicillin+clarithromycinPBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. | Drug | Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days |
| Vonoprazan+amoxicillin+clarithromycin 14 daysVAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid. | Drug | Vonoprazan+amoxicillin+clarithromycin 14 days |
| Vonoprazan+amoxicillin+clarithromycin 7 daysVAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid. | Drug | Vonoprazan+amoxicillin+clarithromycin 7 days |
| Vonoprazan+tetracycline+furazolidone 14 daysVTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. | Drug | Vonoprazan+tetracycline+furazolidone 14 days |
| Vonoprazan+tetracycline+furazolidone 7 daysVTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. | Drug | Vonoprazan+tetracycline+furazolidone 7 days |
| Vonoprazan+amoxicillin+furazolidone 7 dayshVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid. | Drug | Vonoprazan+amoxicillin+furazolidone 7 days |
| Vonoprazan+amoxicillin+tetracycline 14 dayshVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid. | Drug | Vonoprazan+amoxicillin+tetracycline 14 days |
| Vonoprazan+amoxicillin 7 dayshVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid. | Drug | Vonoprazan+amoxicillin 7 days |
| Vonoprazan+amoxicillin 14 dayshVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid. | Drug | Vonoprazan+amoxicillin 14 days |
Primary outcome
Eradication rate of Helicobacter pylori
Time frame: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).
3 secondary outcomes
Incidence of adverse effects
Time frame: 14 days of treatment, and 28 days after treatment
Treatment compliance
Time frame: 7 or 14 days of treatment
Symptom relief rate
Time frame: 14 days of treatment, and 28 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes
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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 Rabeprazloe+bismuth+amoxicillin+clarithromycin, Vonoprazan+amoxicillin+clarithromycin 14 days and Vonoprazan+amoxicillin+clarithromycin 7 days in people with the Eradication Rates of Helicobacter Pylori, run by Xijing Hospital of Digestive Diseases 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 1 inclusion and 1 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 13 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori (time frame: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment). 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 13 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.