Helicobacter Pylori InfectionNCT06340334
Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study
A study testing Tegoprazan-amoxicillin dual therapy in people with Helicobacter Pylori Infection and Tegoprazan, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Tegoprazan, Furazolidone
- What is being tested?
- Tegoprazan-amoxicillin dual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2024to 10 Sep 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old;
- Patients who have had a positive 13C or 14C breath test and have not received Helicobacter pylori eradication therapy before, or who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
- Voluntarily join this trial and sign the informed consent form.
Who cannot join
- Allergy to the study drug (penicillin, amoxicillin, furazolidone, Tegoprazan, etc.);
- Patients with active peptic ulcer disease;
- Patients who have received Helicobacter pylori eradication therapy within half a year;
- Use of antibiotics, bismuth, histamine H2 receptor antagonists or PPIs for 4 weeks before starting study treatment;
- use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants;
- History of esophageal or gastric surgery;
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- Pregnant or lactating women;
- Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
- Alcoholism.
- Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.
Read the detailed description
This study is a prospective, multicenter, open-label, randomized, parallel-controlled study. A total of 600 Hp-positive patients who had not received Hp eradication therapy before or who had previously eradicated Hp but had not undergone eradication therapy in the past six months were recruited, and the basic clinical data of the patients (age, gender, drug allergy history, diagnosis and treatment, etc.) were recorded, and they were randomly divided into two groups according to the ratio of 1:1. Group A subjects received oral Tegoprazan 50mg, bid + amoxicillin 1000mg, tid; Group B subjects received oral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days.
During the 14-day eradication treatment period, all participants were asked to record their adverse reactions and adherence to the medication. On the 7th and 14th days of medication, the researchers will conduct follow-up visits through WeChat or telephone to determine the adverse reactions and compliance of the patients, and observe and record whether the subjects have nausea, diarrhea, dizziness, bitter mouth, rash, constipation and other adverse reactions. In addition, subjects returned to the hospital 4-6 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT.
- Conditions
- Helicobacter Pylori Infection, Tegoprazan, Furazolidone
- Being tested
- Tegoprazan-amoxicillin dual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan-amoxicillin dual therapyBiological
Also called Furazolidone-based Bismuth Quadruple Therapy
A total of 600 Hp-positive patients who had not received Hp eradication therapy before or had had Hp eradication in the early stage but had not undergone eradication therapy in the past six months were randomly divided into two groups: group A subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, tid; Group B subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days. The eradication rate, adverse reactions, and compliance of the two groups were compared.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | oral Tegoprazan 50 mg, bid+amoxicillin 1000 mg, tid. The duration of treatment is 14 days. Receives: Biological: Tegoprazan-amoxicillin dual therapy |
| Group B | Active comparator | oral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days. Receives: Biological: Tegoprazan-amoxicillin dual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
The eradication effect of Helicobacter pylori was detected by 13C-UBT or 14C-UBT
Measured: 4-6 weeks after the end of the last dose
Secondary outcomes (1)
Security observations
Adverse reactions such as nausea, diarrhea, dizziness, change in taste, rash, constipation, etc
Measured: Days 7 and 14 of eradication treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start31 Mar 2024
- Primary completion1 Sep 2025
- Study completion10 Sep 2025
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 Nanjing First Hospital, Nanjing Medical 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
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340334
- Sponsor's protocol ID
- KY20240123-05
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang H, Qu Y, Wang J, Yao J, Yang Z, Shen L, Ye X, Fei C, Xi M, Xu M, Ge J, Zhang Z, Zhang Z. Tegoprazan-based dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. Sci Rep. 2026 Jul 15. doi: 10.1038/s41598-026-62237-4. Online ahead of print.
PubMed 42457948
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06340334
- Acronym / sponsor ID
- KY20240123-05
- Conditions
- Helicobacter Pylori Infection, Tegoprazan, Furazolidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 1 Apr 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.
To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.
Detailed description
This study is a prospective, multicenter, open-label, randomized, parallel-controlled study. A total of 600 Hp-positive patients who had not received Hp eradication therapy before or who had previously eradicated Hp but had not undergone eradication therapy in the past six months were recruited, and the basic clinical data of the patients (age, gender, drug allergy history, diagnosis and treatment, etc.) were recorded, and they were randomly divided into two groups according to the ratio of 1:1. Group A subjects received oral Tegoprazan 50mg, bid + amoxicillin 1000mg, tid; Group B subjects received oral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days.
During the 14-day eradication treatment period, all participants were asked to record their adverse reactions and adherence to the medication. On the 7th and 14th days of medication, the researchers will conduct follow-up visits through WeChat or telephone to determine the adverse reactions and compliance of the patients, and observe and record whether the subjects have nausea, diarrhea, dizziness, bitter mouth, rash, constipation and other adverse reactions. In addition, subjects returned to the hospital 4-6 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Tegoprazan-amoxicillin dual therapyoral Tegoprazan 50 mg, bid+amoxicillin 1000 mg, tid. The duration of treatment is 14 days. |
| Group B | Active comparator | Biological: Tegoprazan-amoxicillin dual therapyoral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old;
- Patients who have had a positive 13C or 14C breath test and have not received Helicobacter pylori eradication therapy before, or who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
- Voluntarily join this trial and sign the informed consent form.
Key exclusion criteria (10 listed)
- Allergy to the study drug (penicillin, amoxicillin, furazolidone, Tegoprazan, etc.);
- Patients with active peptic ulcer disease;
- Patients who have received Helicobacter pylori eradication therapy within half a year;
- Use of antibiotics, bismuth, histamine H2 receptor antagonists or PPIs for 4 weeks before starting study treatment;
- use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants;
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 |
|---|---|---|
| Tegoprazan-amoxicillin dual therapyAlso: Furazolidone-based Bismuth Quadruple TherapyA total of 600 Hp-positive patients who had not received Hp eradication therapy before or had had Hp eradication in the early stage but had not undergone eradication therapy in the past six months were randomly divided into two groups: group A subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, tid; Group B subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days. The eradication rate, adverse reactions, and compliance of the two groups were compared. | Biological | Group A, Group B |
Primary outcome
Helicobacter pylori eradication rate
Time frame: 4-6 weeks after the end of the last dose
The eradication effect of Helicobacter pylori was detected by 13C-UBT or 14C-UBT
1 secondary outcome
Security observations
Time frame: Days 7 and 14 of eradication treatment
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 5 Mar 2026.
- Derived from this study: PubMed 42457948Wang H, Qu Y, Wang J, Yao J, Yang Z, Shen L, Ye X, Fei C, Xi M, Xu M, Ge J, Zhang Z, Zhang Z. Tegoprazan-based dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. Sci Rep. 2026 Jul 15. doi: 10.1038/s41598-026-62237-4. Online ahead of print.
- 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.
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 Tegoprazan-amoxicillin dual therapy in people with Helicobacter Pylori Infection and Tegoprazan, run by Nanjing First Hospital, Nanjing Medical 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 3 inclusion and 10 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 5 Mar 2026. 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: 4-6 weeks after the end of the last dose). 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 NCT06340334, 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 5 Mar 2026.