H.Pylori InfectionNCT06682533
Tegoprazan- Versus PPI-based H. Pylori Eradication
An observational study of H.Pylori Infection, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- H.Pylori Infection
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2024to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: H. pylori-infected patients
Who may be able to join
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
Who cannot join
- Age < 20 or > 80 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- History of H. pylori eradication
Show all 9Show fewer
- Drug allergy to antibiotics
- History of gastric surgery
- Recent history of upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, 04401
Jun-Hyung Cho, M.D., +82-2-709-9202, chojhmd@naver.com
About this study
Official title: Efficacy and Tolerability of 14-Day Tegoprazan-based Triple Therapy for Eradication of Helicobacter Pylori Eradication: A Retrospective Study
In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.
Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.
Read the detailed description
The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.
- Conditions
- H.Pylori Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PPI-BID group | Standard dose of PPI bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days | |
| Tegoprazan-BID group | Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days | |
| PPI-QID group | Standard dose of PPI bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days | |
| Tegoprazan-QID group | Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid,tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rates
Urea breath test after completing H. pylori eradication regimen
Measured: 6 weeks
Secondary outcomes (2)
Treatment compliance
Assessment of patients' numbers completing H. pylori eradication regimen
Measured: 6 weeks
Drug-related adverse event rate
Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H.Pylori InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682533
- Sponsor's protocol ID
- SCH-HP-2024-11
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2024
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of 14-Day Tegoprazan-based Triple Therapy for Eradication of Helicobacter Pylori Eradication: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06682533
- Acronym / sponsor ID
- SCH-HP-2024-11
- Conditions
- H.Pylori Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Nov 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.
In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.
Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.
Detailed description
The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PPI-BID group | – | –Standard dose of PPI bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days |
| Tegoprazan-BID group | – | –Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days |
| PPI-QID group | – | –Standard dose of PPI bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days |
| Tegoprazan-QID group | – | –Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid,tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- H. pylori-infected patients
Key inclusion criteria (2 listed)
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
Key exclusion criteria (9 listed)
- Age < 20 or > 80 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
H. pylori eradication rates
Time frame: 6 weeks
Urea breath test after completing H. pylori eradication regimen
2 secondary outcomes
Treatment compliance
Time frame: 6 weeks
Drug-related adverse event rate
Time frame: 6 weeks
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 23 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for H.Pylori Infection
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European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
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Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
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Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS
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Factors Affecting Helicobacter Pylori Infection: Diet and Lifestyle Patterns
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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.
Jun-Hyung Cho, M.D. principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of H.Pylori Infection, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 9 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: looking for participants now, as of the sponsor's last update on 23 Apr 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 South Korea. 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?
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?
Contact Jun-Hyung Cho (+82-2-709-9202 ext. 9581, chojhmd@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rates (time frame: 6 weeks). 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 23 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.