Helicobacter Pylori Infection Chronic GastritPhase 4NCT06523764
Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment
A Phase 4 study testing tegoprazan, Minocycline and bismuth potassium citrate in people with Helicobacter Pylori Infection Chronic Gastrit, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection Chronic Gastrit
- What is being tested?
- tegoprazan, Minocycline and bismuth potassium citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 between 18~70,both gender.
- Patients with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th
Who cannot join
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- Constant use of anti-ulcer drugs ( including taking proton- pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- Patients with moderate to severe dysplasia or high degree of intraepithelial neopla
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- Patients have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- Patients who has psychological problem or poor compliance.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed conse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment : A Randomized Controlled Trial
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
- Being tested
- tegoprazan, Minocycline, bismuth potassium citrate, Esomeprazole 40mg, Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tegoprazanDrug
Also called minocycline
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
MinocyclineDrug
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
bismuth potassium citrateDrug
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
Esomeprazole 40mgDrug
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
AmoxicillinDrug
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
clarithromycinDrug
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| tegoprazan and minocycline dual theropy | Experimental | tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days Receives: Drug: tegoprazan; Drug: Minocycline |
| Bismuth-containing quadruple therapy | Active comparator | bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days Receives: Drug: bismuth potassium citrate; Drug: Esomeprazole 40mg; Drug: Amoxicillin; Drug: clarithromycin |
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 urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament
Measured: 28 days after treatment
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events (Safety)
Newly occurring drug-related symptoms during the treatment process
Measured: 14 days of treatment
Rate of participants with good medication compliance (Compliance)
Taking more than 80% of medication is defined as good compliance
Measured: 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start11 Nov 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infection Chronic GastritStudies 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
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
- Investigators
- Yongquan Shi,, Principal investigator, Chinaa, Shaanxi Xijing Hosipital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523764
- Sponsor's protocol ID
- KY20242230-C-1
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06523764
- Acronym / sponsor ID
- KY20242230-C-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Jul 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.
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tegoprazan and minocycline dual theropy | Experimental | Drug: tegoprazan, Drug: Minocyclinetegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days |
| Bismuth-containing quadruple therapy | Active comparator | Drug: bismuth potassium citrate, Drug: Esomeprazole 40mg, Drug: Amoxicillin, Drug: clarithromycinbismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 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 between 18~70,both gender.
- Patients with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th
Key exclusion criteria (14 listed)
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- Constant use of anti-ulcer drugs ( including taking proton- pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Pregnant or lactating women.
- Underwent 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 |
|---|---|---|
| tegoprazanAlso: minocyclinetegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days | Drug | tegoprazan and minocycline dual theropy |
| Minocyclinetegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days | Drug | tegoprazan and minocycline dual theropy |
| bismuth potassium citratebismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days | Drug | Bismuth-containing quadruple therapy |
| Esomeprazole 40mgbismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days | Drug | Bismuth-containing quadruple therapy |
| Amoxicillinbismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days | Drug | Bismuth-containing quadruple therapy |
| clarithromycinbismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days | Drug | Bismuth-containing quadruple therapy |
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 urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety)
Time frame: 14 days of treatment
Rate of participants with good medication compliance (Compliance)
Time frame: 14 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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.
Yongquan Shi, principal investigator
Chinaa, Shaanxi 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 tegoprazan, Minocycline and bismuth potassium citrate in people with Helicobacter Pylori Infection Chronic Gastrit, 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 14 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: 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 3 Jul 2025.