Helicobacter PyloriPhase 4NCT05345210
Vonoprazan Hp Dual or Triple Eradication Regimes
A Phase 4 study testing Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14), Vonoprazan Fumarate+Amoxycillin 14days (VA14) and Vonoprazan Fumarate+Amoxycillin 7days (VA7) in people with Helicobacter Pylori, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14), Vonoprazan Fumarate+Amoxycillin 14days (VA14) and Vonoprazan Fumarate+Amoxycillin 7days (VA7)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 31 Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old, both gender is eligiable;
- Patients with definite Helicobacter Pylori infection (13C/14C urea breath test, rapid urease test and fecal Helicobacter Pylori antigen test positive) ;
- Voluntary to accept Helicobacter Pylori eradication treatment;
- Females of childbearing age are required to use medically acceptable contraceptive methods during the trial and within 30 days after the trial.
Who cannot join
- Patients with contraindications to the study drug or allergic to the study drug;
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (at least 2 weeks before the examination for Helicobacter Pylori infection);
- Pregnant and lactating women;
- Have received upper gastrointestinal surgery;
- Symptoms of dysphagia;
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- Evidence of bleeding or iron deficiency anemia;
- have a history of malignant tumor;
- History of drug or alcohol abuse within the past 1 year;
- Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, and platelet aggregation inhibitors (except aspirin ≤100 mg/d);
- Persons with mental disorders;
- Received other clinical trials within the past 3 months;
- Refused to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032
Ying Han, Ph.D, 86-29-84771539, hanying@fmmu.edu.cn
Yongquan Shi, Ph.D, 86-29-84771515, shiyquan@fmmu.edu.cn
About this study
Official title: Efficacy and Safety of Helicobacter Pylori Eradication Dual or Triple Regimes Using Vonoprazan as the Antacid
To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.
- Conditions
- Helicobacter Pylori
- Being tested
- Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14), Vonoprazan Fumarate+Amoxycillin 14days (VA14), Vonoprazan Fumarate+Amoxycillin 7days (VA7), Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14), Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)Drug
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Vonoprazan Fumarate+Amoxycillin 14days (VA14)Drug
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Vonoprazan Fumarate+Amoxycillin 7days (VA7)Drug
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)Drug
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)Drug
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) | Active comparator | Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days Receives: Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) |
| Vonoprazan Fumarate+Amoxycillin 14days (VA14) | Experimental | Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days Receives: Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14) |
| Vonoprazan Fumarate+Amoxycillin 7days (VA7) | Experimental | Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days Receives: Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7) |
| Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) | Experimental | Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days Receives: Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) |
| Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) | Experimental | Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days Receives: Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter Pylori eradication rate
The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication
Measured: 28 days after treatment
Secondary outcomes (2)
symptoms effective rates
symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe
Measured: 14 days of treatment, and 28 days after treatment
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 posted25 Apr 2022
- Study start25 Apr 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 500 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
- Investigators
- Ying Han, Principal investigator, Xijing Hosipital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345210
- Sponsor's protocol ID
- XJLL-KY20222010
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Helicobacter Pylori Eradication Dual or Triple Regimes Using Vonoprazan as the Antacid
- ClinicalTrials.gov ID
- NCT05345210
- Acronym / sponsor ID
- XJLL-KY20222010
- Conditions
- Helicobacter Pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 Apr 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.
To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) | Active comparator | Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days |
| Vonoprazan Fumarate+Amoxycillin 14days (VA14) | Experimental | Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14)Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days |
| Vonoprazan Fumarate+Amoxycillin 7days (VA7) | Experimental | Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7)Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days |
| Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) | Experimental | Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days |
| Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) | Experimental | Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 70 years old, both gender is eligiable;
- Patients with definite Helicobacter Pylori infection (13C/14C urea breath test, rapid urease test and fecal Helicobacter Pylori antigen test positive) ;
- Voluntary to accept Helicobacter Pylori eradication treatment;
- Females of childbearing age are required to use medically acceptable contraceptive methods during the trial and within 30 days after the trial.
Key exclusion criteria (13 listed)
- Patients with contraindications to the study drug or allergic to the study drug;
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (at least 2 weeks before the examination for Helicobacter Pylori infection);
- Pregnant and lactating women;
- Have received upper gastrointestinal surgery;
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 |
|---|---|---|
| Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days | Drug | Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) |
| Vonoprazan Fumarate+Amoxycillin 14days (VA14)VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days | Drug | Vonoprazan Fumarate+Amoxycillin 14days (VA14) |
| Vonoprazan Fumarate+Amoxycillin 7days (VA7)VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days | Drug | Vonoprazan Fumarate+Amoxycillin 7days (VA7) |
| Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days | Drug | Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) |
| Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days | Drug | Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) |
Primary outcome
Helicobacter Pylori eradication rate
Time frame: 28 days after treatment
The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication
2 secondary outcomes
symptoms effective rates
Time frame: 14 days of treatment, and 28 days after treatment
adverse events
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 20 Oct 2022.
- 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. This study is not recruiting at the moment.
Ying Han principal investigator
Xijing Hosipital of Digestive Disease
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 Fumarate+Amoxycillin+Clarithromycin 14days (VAC14), Vonoprazan Fumarate+Amoxycillin 14days (VA14) and Vonoprazan Fumarate+Amoxycillin 7days (VA7) in people with 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 4 inclusion and 13 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 20 Oct 2022. 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 Jiaqiang Dong (86-029-84771506, dongjiaqiang1988@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: 28 days after 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 20 Oct 2022.