Helicobacter Pylori InfectionNCT06250634
Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection
A study testing esomeprazole + amoxicillin, esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent and Vonoprazan + amoxicillin in people with Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin +… Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- esomeprazole + amoxicillin, esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent and Vonoprazan + amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2024to 10 May 2024
- Phase
- Interventional
- 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 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients aged 14-90 years, no requirement for gender;
- patients diagnosed as H. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13C/14C-UBT) or immuno-histochemical staining of biopsy specimens;
- patients with no use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C/14C-UBT, and no H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H .pylori activity within the previous 2 weeks of 13C/14C-UBT;
- patients without history of receiving H. pylori eradication therapy.
Who cannot join
- patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
- patients with allergy to penicillin or any research-program-related drugs;
- patients with mental illness and communication disorders;
- patients in pregnancy or lactation;
- patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
- patients who were participating in other clinical trials;
- patients who were considered inappropriate for enrollment after evaluation by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Esomeprazole / Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection: a Multi-center, Prospective, Open-label, Randomized Controlled Clinical Trial
This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- esomeprazole + amoxicillin, esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent, Vonoprazan + amoxicillin, Vonoprazan + amoxicillin + clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole + amoxicillinDrug
esomeprazole enteric-coated tablets (AstraZeneca) 20mg four times daily and amoxicillin capsules (Hainan General Sanyang Pharmaceutical) 750mg four times daily
esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agentDrug
20mg twice daily of esomeprazole enteric-coated tablets, 1000 mg twice daily of amoxicillin capsules, 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical) and 165 mg three times daily of colloidal bismuth tartrate capsules (Shanxi Xinbaoyuan Pharmaceutical)
Vonoprazan + amoxicillinDrug
20 mg twice daily of vonoprazan fumarate tablets (Takeda Pharmaceutical Company Limited) and 1000 mg three times daily of amoxicillin capsules (Hainan General Sanyang Pharmaceutical)
Vonoprazan + amoxicillin + clarithromycinDrug
20 mg twice daily of vonoprazan fumarate tablets, 1000 mg twice daily of amoxicillin capsules and 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical)
| Study group | Role | What they receive |
|---|---|---|
| Double group ( Esomeprazole ) | Experimental | Not described Receives: Drug: esomeprazole + amoxicillin |
| Quadruple group ( Esomeprazole ) | Active comparator | Not described Receives: Drug: esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent |
| Double group ( Vonoprazan ) | Experimental | Not described Receives: Drug: Vonoprazan + amoxicillin |
| Triple group (Vonoprazan ) | Active comparator | Not described Receives: Drug: Vonoprazan + amoxicillin + clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
carbon-13/14 urea breath test
Measured: pre-intervention and at least 30 days post-intervention
Secondary outcomes (2)
Adverse events
Measured: the 3rd, 7th, and 14th day during the intervention
Compliance
Measured: the 14th day during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Feb 2024
- Primary completion10 May 2024
- Study completion10 May 2024
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 The Third Xiangya Hospital of Central South UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Huaihua, Yueyang Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Fen Wang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250634
- Sponsor's protocol ID
- Fast 21292, Fast 23359
- Status last verified
- May 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 May 2024
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esomeprazole / Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection: a Multi-center, Prospective, Open-label, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06250634
- Acronym / sponsor ID
- Fast 21292, Fast 23359
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Huaihua, Yueyang Hospital of Traditional Chinese Medicine
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 9 Feb 2024 (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 intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Double group ( Esomeprazole ) | Experimental | Drug: esomeprazole + amoxicillin |
| Quadruple group ( Esomeprazole ) | Active comparator | Drug: esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent |
| Double group ( Vonoprazan ) | Experimental | Drug: Vonoprazan + amoxicillin |
| Triple group (Vonoprazan ) | Active comparator | Drug: Vonoprazan + amoxicillin + clarithromycin |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged 14-90 years, no requirement for gender;
- patients diagnosed as H. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13C/14C-UBT) or immuno-histochemical staining of biopsy specimens;
- patients with no use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C/14C-UBT, and no H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H .pylori activity within the previous 2 weeks of 13C/14C-UBT;
- patients without history of receiving H. pylori eradication therapy.
Key exclusion criteria (7 listed)
- patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
- patients with allergy to penicillin or any research-program-related drugs;
- patients with mental illness and communication disorders;
- patients in pregnancy or lactation;
- patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
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 |
|---|---|---|
| esomeprazole + amoxicillinesomeprazole enteric-coated tablets (AstraZeneca) 20mg four times daily and amoxicillin capsules (Hainan General Sanyang Pharmaceutical) 750mg four times daily | Drug | Double group ( Esomeprazole ) |
| esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent20mg twice daily of esomeprazole enteric-coated tablets, 1000 mg twice daily of amoxicillin capsules, 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical) and 165 mg three times daily of colloidal bismuth tartrate capsules (Shanxi Xinbaoyuan Pharmaceutical) | Drug | Quadruple group ( Esomeprazole ) |
| Vonoprazan + amoxicillin20 mg twice daily of vonoprazan fumarate tablets (Takeda Pharmaceutical Company Limited) and 1000 mg three times daily of amoxicillin capsules (Hainan General Sanyang Pharmaceutical) | Drug | Double group ( Vonoprazan ) |
| Vonoprazan + amoxicillin + clarithromycin20 mg twice daily of vonoprazan fumarate tablets, 1000 mg twice daily of amoxicillin capsules and 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical) | Drug | Triple group (Vonoprazan ) |
Primary outcome
Helicobacter pylori eradication rate
Time frame: pre-intervention and at least 30 days post-intervention
carbon-13/14 urea breath test
2 secondary outcomes
Adverse events
Time frame: the 3rd, 7th, and 14th day during the intervention
Compliance
Time frame: the 14th day during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esomeprazole + amoxicillin, esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent and Vonoprazan + amoxicillin in people with Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University 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 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: finished, as of the sponsor's last update on 29 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: pre-intervention and at least 30 days post-intervention). 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 29 May 2024.