Helicobacter Pylori InfectionPhase 4NCT04907747
Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication
A Phase 4 study testing Vonoprazan, Esomeprazole and Colloidal bismuth pectin 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 vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan, Esomeprazole and Colloidal bismuth pectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2021to 13 Apr 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain or bacterium culture
- 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
- Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
- 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
- Pregnancy or in lactation
- 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: Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial
This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.
Read the detailed description
Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising.
This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups.
Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Esomeprazole, Colloidal bismuth pectin, Amoxicillin, Furazolidone
- Keywords
- Helicobacter pylori, vonoprazan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Potassium-competitive acid blocker
EsomeprazoleDrug
Proton pump inhibitor
Colloidal bismuth pectinDrug
Gastric mucosal protective drug with anti-H. pylori effect
AmoxicillinDrug
Antibiotic for H. pylori eradication
FurazolidoneDrug
Antibiotic for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days | Experimental | Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days Receives: Drug: Vonoprazan; Drug: Colloidal bismuth pectin; Drug: Amoxicillin; Drug: Furazolidone |
| Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days | Experimental | Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Receives: Drug: Vonoprazan; Drug: Colloidal bismuth pectin; Drug: Amoxicillin; Drug: Furazolidone |
| Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days | Active comparator | Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Receives: Drug: Esomeprazole; Drug: Colloidal bismuth pectin; Drug: Amoxicillin; Drug: Furazolidone |
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.
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 posted1 Jun 2021
- Study start18 May 2021 (estimated)
- Primary completion13 Apr 2022 (estimated)
- Study completion13 Apr 2022 (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 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
- 234 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907747
- Sponsor's protocol ID
- 2021-0446
- Status last verified
- Apr 2021
- First submitted
- 24 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu L, Wang Y, Ye J, Han Y, Lou G, Li Y, Yan H, Du Q. Quadruple therapy with vonoprazan 20 mg daily as a first-line treatment for Helicobacter pylori infection: A single-center, open-label, noninferiority, randomized controlled trial. Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1.
PubMed 36458325
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04907747
- Acronym / sponsor ID
- 2021-0446
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, vonoprazan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 May 2021 (estimated)
- Primary completion
- 13 Apr 2022 (estimated)
- Study completion
- 13 Apr 2022 (estimated)
- First posted
- 1 Jun 2021 (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 compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.
Detailed description
Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising.
This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups.
Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days | Experimental | Drug: Vonoprazan, Drug: Colloidal bismuth pectin, Drug: Amoxicillin, Drug: FurazolidoneVonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days |
| Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days | Experimental | Drug: Vonoprazan, Drug: Colloidal bismuth pectin, Drug: Amoxicillin, Drug: FurazolidoneVonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days |
| Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days | Active comparator | Drug: Esomeprazole, Drug: Colloidal bismuth pectin, Drug: Amoxicillin, Drug: FurazolidoneEsomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain or bacterium culture
- With no historical treatment for helicobacter pylori infection.
Key exclusion criteria (7 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
- Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
- 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
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 | Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days, Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days |
| EsomeprazoleProton pump inhibitor | Drug | Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days |
| Colloidal bismuth pectinGastric mucosal protective drug with anti-H. pylori effect | Drug | Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days, Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days, Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days, Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days, Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days |
| FurazolidoneAntibiotic for H. pylori eradication | Drug | Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days, Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days, Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days |
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.
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 1 Jun 2021.
- Derived from this study: PubMed 36458325Lu L, Wang Y, Ye J, Han Y, Lou G, Li Y, Yan H, Du Q. Quadruple therapy with vonoprazan 20 mg daily as a first-line treatment for Helicobacter pylori infection: A single-center, open-label, noninferiority, randomized controlled trial. Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1.
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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, Esomeprazole and Colloidal bismuth pectin 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 2 inclusion and 7 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 1 Jun 2021. 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?
On the ClinicalTrials.gov record for NCT04907747, 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 1 Jun 2021.