Helicobacter Pylori InfectionPhase 4NCT05419674
Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection
A Phase 4 study testing Vonoprazan, Rabeprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan, Rabeprazole and Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Aug 2023
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
- underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
- with no historical treatment for helicobacter pylori infection.
Who cannot join
- administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
- with previous esophageal or gastric surgery
- with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
- allergy to any of the study drugs
- participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
Qin Du, Master, +86 0571-89713734, duq518@163.com
About this study
Official title: Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial
This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Rabeprazole, Amoxicillin, Clarithromycin, Colloidal bismuth pectin
- Keywords
- dual therapy, bismuth-containing quadruple therapy, Helicobacter Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Potassium-competitive acid blocker
RabeprazoleDrug
Proton pump inhibitor
AmoxicillinDrug
Antibiotic for H. pylori eradication
ClarithromycinDrug
Antibiotic for H. pylori eradication
Colloidal bismuth pectinDrug
Gastric mucosal protective drug with anti-H. pylori effect
| Study group | Role | What they receive |
|---|---|---|
| groupA: dual therapy (vonoprazan+amoxicillin) | Experimental | vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days Receives: Drug: Vonoprazan; Drug: Amoxicillin |
| group B: dual therapy (rabeprazole+amoxicillin) | Experimental | rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days Receives: Drug: Rabeprazole; Drug: Amoxicillin |
| group C: bismuth-containing quadruple therapy | Active comparator | rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days Receives: Drug: Rabeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Colloidal bismuth pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori Eradication Rate
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Measured: Six to eight weeks after completion of the medication
Secondary outcomes (2)
Rate of Adverse Drug Reaction(ADR)
Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).
Measured: Within 7 days after completion of therapy
Compliance Rate
Compliance was defined as poor when they had taken less than 80% of the total medication.
Measured: Within 7 days after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 393 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419674
- Sponsor's protocol ID
- 2022-0323
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 16 Feb 2023
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05419674
- Acronym / sponsor ID
- 2022-0323
- Conditions
- Helicobacter Pylori Infection
- Keywords
- dual therapy, bismuth-containing quadruple therapy, Helicobacter Pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 393 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 15 Jun 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.
This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| groupA: dual therapy (vonoprazan+amoxicillin) | Experimental | Drug: Vonoprazan, Drug: Amoxicillinvonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days |
| group B: dual therapy (rabeprazole+amoxicillin) | Experimental | Drug: Rabeprazole, Drug: Amoxicillinrabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days |
| group C: bismuth-containing quadruple therapy | Active comparator | Drug: Rabeprazole, Drug: Amoxicillin, Drug: Clarithromycin, Drug: Colloidal bismuth pectinrabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
- underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
- with no historical treatment for helicobacter pylori infection.
Key exclusion criteria (5 listed)
- administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
- with previous esophageal or gastric surgery
- with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
- allergy to any of the study drugs
- participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
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 |
|---|---|---|
| VonoprazanPotassium-competitive acid blocker | Drug | groupA: dual therapy (vonoprazan+amoxicillin) |
| RabeprazoleProton pump inhibitor | Drug | group B: dual therapy (rabeprazole+amoxicillin), group C: bismuth-containing quadruple therapy |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | group B: dual therapy (rabeprazole+amoxicillin), group C: bismuth-containing quadruple therapy, groupA: dual therapy (vonoprazan+amoxicillin) |
| ClarithromycinAntibiotic for H. pylori eradication | Drug | group C: bismuth-containing quadruple therapy |
| Colloidal bismuth pectinGastric mucosal protective drug with anti-H. pylori effect | Drug | group C: bismuth-containing quadruple therapy |
Primary outcome
Helicobacter pylori Eradication Rate
Time frame: Six to eight weeks after completion of the medication
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
2 secondary outcomes
Rate of Adverse Drug Reaction(ADR)
Time frame: Within 7 days after completion of therapy
Compliance Rate
Time frame: Within 7 days after completion of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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, Rabeprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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 16 Feb 2023. 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?
Contact Qin Du, Master (+86 0571-89713734, duq518@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori Eradication Rate (time frame: Six to eight weeks after completion of the medication). 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 16 Feb 2023.