Helicobacter Pylori InfectionPhase 3NCT04128917
Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT
A Phase 3 study testing Tegoprazan and RAPAE01 in people with Helicobacter Pylori Infection, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 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 and RAPAE01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2020to 29 Jan 2021
- Phase
- Phase 3
- 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.
About this study
Official title: A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Triple Therapy With Tegoprazan, Amoxicillin and Clarithromycin in H. Pylori Positive Patients
This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.
Read the detailed description
A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan, RAPAE01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
RAPAE01Drug
RAPAE01/Clarithromycin/Amoxicillin BID peroral
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Tegoprazan 50 mg Triple Therapy Receives: Drug: Tegoprazan |
| Tegoprazan 100 mg | Experimental | Tegoprazan 100 mg Triple Therapy Receives: Drug: Tegoprazan |
| RAPAE01 | Active comparator | RAPAE01 Triple Therapy Receives: Drug: RAPAE01 |
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: Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start21 Jan 2020
- Primary completion21 Dec 2020
- Study completion29 Jan 2021
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 HK inno.N CorporationThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JAEGYU KIM, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128917
- Sponsor's protocol ID
- CJ_APA_E01
- Status last verified
- May 2021
- First submitted
- 15 Oct 2019
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JY, Choi IJ, Kim GH, Hong SJ, Shin SK, Jeon SW, Kim JG. Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study. Gut Liver. 2025 Sep 15;19(5):696-705. doi: 10.5009/gnl250067. Epub 2025 Jun 4.
PubMed 40462641
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Triple Therapy With Tegoprazan, Amoxicillin and Clarithromycin in H. Pylori Positive Patients
- ClinicalTrials.gov ID
- NCT04128917
- Acronym / sponsor ID
- CJ_APA_E01
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 16 Oct 2019 (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 aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.
Detailed description
A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.
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: TegoprazanTegoprazan 50 mg Triple Therapy |
| Tegoprazan 100 mg | Experimental | Drug: TegoprazanTegoprazan 100 mg Triple Therapy |
| RAPAE01 | Active comparator | Drug: RAPAE01RAPAE01 Triple Therapy |
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 |
|---|---|---|
| TegoprazanTegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral | Drug | Tegoprazan 100 mg, Tegoprazan 50 mg |
| RAPAE01RAPAE01/Clarithromycin/Amoxicillin BID peroral | Drug | RAPAE01 |
Primary outcome
H. pylori eradication rate
Time frame: Day 49
Assess H. pylori eradication rate by UBT
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 12 May 2021.
- Derived from this study: PubMed 40462641Park JY, Choi IJ, Kim GH, Hong SJ, Shin SK, Jeon SW, Kim JG. Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study. Gut Liver. 2025 Sep 15;19(5):696-705. doi: 10.5009/gnl250067. Epub 2025 Jun 4.
- 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.
JAEGYU 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 3 study testing Tegoprazan and RAPAE01 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: finished, as of the sponsor's last update on 12 May 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
H. pylori eradication rate (time frame: Day 49). 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 NCT04128917, 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 12 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.