Helicobacter Pylori InfectionPhase 2NCT05933031
Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
A Phase 2 study testing Tegoprazan 50 mg Triple Therapy, Tegoprazan 100 mg Triple Therapy and Lansoprazole Triple Therapy in people with Helicobacter Pylori Infection, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan 50 mg Triple Therapy, Tegoprazan 100 mg Triple Therapy and Lansoprazole Triple Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Feb 2023to 31 Dec 2024
- Phase
- Phase 2
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H. pylori positive at screening
- Subjects who have upper gastrointestinal disease
Who cannot join
- Having received prior therapy for eradication of H. pylori
- Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
- Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hosptial
Seoul
About this study
Official title: A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.
Read the detailed description
A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan 50 mg Triple Therapy, Tegoprazan 100 mg Triple Therapy, Lansoprazole Triple Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50 mg Triple TherapyDrug
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Tegoprazan 100 mg Triple TherapyDrug
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Lansoprazole Triple TherapyDrug
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days Receives: Drug: Tegoprazan 50 mg Triple Therapy |
| Tegoprazan 100 mg | Experimental | Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days Receives: Drug: Tegoprazan 100 mg Triple Therapy |
| Lansoprazole | Active comparator | Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days Receives: Drug: Lansoprazole Triple Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Assess H. pylori eradication rate by UBT
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start27 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 381 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Gyu Kim, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933031
- Sponsor's protocol ID
- IN_APA_E02
- Status last verified
- Jul 2023
- First submitted
- 23 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JY, Hong SJ, Choi IJ, Baik GH, Kim SM, Park JJ, Jeon SW, Kim KO, Lee SK, Jung HY, Oh JH, Park CH, Kim SW, Shim KN, Jee SR, Moon HS, Moon JS, Choi CW, Lee WS, Kim JG. Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical Trial. Helicobacter. 2026 Jan-Feb;31(1):e70106. doi: 10.1111/hel.70106.
PubMed 41531249
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
- ClinicalTrials.gov ID
- NCT05933031
- Acronym / sponsor ID
- IN_APA_E02
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2023 (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 exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.
Detailed description
A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Drug: Tegoprazan 50 mg Triple TherapyTegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days |
| Tegoprazan 100 mg | Experimental | Drug: Tegoprazan 100 mg Triple TherapyTegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days |
| Lansoprazole | Active comparator | Drug: Lansoprazole Triple TherapyLansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- H. pylori positive at screening
- Subjects who have upper gastrointestinal disease
Key exclusion criteria (3 listed)
- Having received prior therapy for eradication of H. pylori
- Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
- Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days
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 50 mg Triple TherapyTegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days | Drug | Tegoprazan 50 mg |
| Tegoprazan 100 mg Triple TherapyTegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days | Drug | Tegoprazan 100 mg |
| Lansoprazole Triple TherapyLansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days | Drug | Lansoprazole |
Primary outcome
H. pylori eradication rate
Time frame: 42 days
Assess H. pylori eradication rate by UBT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 41531249Park JY, Hong SJ, Choi IJ, Baik GH, Kim SM, Park JJ, Jeon SW, Kim KO, Lee SK, Jung HY, Oh JH, Park CH, Kim SW, Shim KN, Jee SR, Moon HS, Moon JS, Choi CW, Lee WS, Kim JG. Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical Trial. Helicobacter. 2026 Jan-Feb;31(1):e70106. doi: 10.1111/hel.70106.
- 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.
Jae Gyu Kim principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tegoprazan 50 mg Triple Therapy, Tegoprazan 100 mg Triple Therapy and Lansoprazole Triple Therapy in people with Helicobacter Pylori Infection, run by HK inno.N Corporation 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 3 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 6 Jul 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Eun Ji Kim (82-2-6477-0290, eunji.kim24@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: 42 days). 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 NCT05933031, 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 6 Jul 2023.