Helicobacter Pylori InfectionPhase 3NCT03498456
Triple Therapy With Tegoprazan in H. Pylori Positive Patients
A Phase 3 study testing Tegoprazan/Amoxicillin/Clarithromycin and Lansoprazole/Amoxicillin/Clarithromycin in people with Helicobacter Pylori Infection, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan/Amoxicillin/Clarithromycin and Lansoprazole/Amoxicillin/Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2018to 31 Dec 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H. pylori positive based on the screening test
- Peptic ulcer disease
Who cannot join
- Prior treatment for H. pylori eradication
- Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
- Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients
The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.
Read the detailed description
This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan/Amoxicillin/Clarithromycin, Lansoprazole/Amoxicillin/Clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan/Amoxicillin/ClarithromycinDrug
Also called Tegoprazan triple therapy (TAC)
Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Lansoprazole/Amoxicillin/ClarithromycinDrug
Also called Lansoprazole triple therapy (LAC)
Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan/Amoxicillin/Clarithromycin | Experimental | Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg Receives: Drug: Tegoprazan/Amoxicillin/Clarithromycin |
| Lansoprazole/Amoxicillin/Clarithromycin | Active comparator | Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg Receives: Drug: Lansoprazole/Amoxicillin/Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.
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 posted13 Apr 2018
- Study start28 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hwoon Yong Jung, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498456
- Sponsor's protocol ID
- CJ_APA_307
- Status last verified
- May 2020
- First submitted
- 8 Apr 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients
- ClinicalTrials.gov ID
- NCT03498456
- Acronym / sponsor ID
- CJ_APA_307
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Apr 2018 (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 current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.
Detailed description
This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan/Amoxicillin/Clarithromycin | Experimental | Drug: Tegoprazan/Amoxicillin/ClarithromycinTegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg |
| Lansoprazole/Amoxicillin/Clarithromycin | Active comparator | Drug: Lansoprazole/Amoxicillin/ClarithromycinLansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- H. pylori positive based on the screening test
- Peptic ulcer disease
Key exclusion criteria (3 listed)
- Prior treatment for H. pylori eradication
- Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
- Prior use of H. pylori eradication effective antibiotics, bismuth within 14 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/Amoxicillin/ClarithromycinAlso: Tegoprazan triple therapy (TAC)Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening. | Drug | Tegoprazan/Amoxicillin/Clarithromycin |
| Lansoprazole/Amoxicillin/ClarithromycinAlso: Lansoprazole triple therapy (LAC)Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening. | Drug | Lansoprazole/Amoxicillin/Clarithromycin |
Primary outcome
H. pylori eradication rate
Time frame: 6 weeks
Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.
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 8 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Hwoon Yong Jung, Professor principal investigator
Asan Medical Center
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/Amoxicillin/Clarithromycin and Lansoprazole/Amoxicillin/Clarithromycin 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 8 May 2020. 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: 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 8 May 2020.