Helicobacter Pylori InfectionPhase 4NCT03130452
Helicobacter Pylori Eradication Study
A Phase 4 study testing Lansoprazole 30mg, Amoxicillin 1.0g Tab and Clarithromycin 500mg in people with Helicobacter Pylori Infection, run by Inje University at 1 site in South Korea.
Trial summary
The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Lansoprazole 30mg, Amoxicillin 1.0g Tab and Clarithromycin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2016to 31 May 2019
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H. pylori infection diagnosed patient, between 18 years old and 80 years old
- No history of H. pylori eradication therapy
- No antibiotic use for more than 3 days within 1 month of treatment
Who cannot join
- History of taking antibiotics for more than 3 days in the last 1 month
- History of subtotal or partial gastrectomy
- Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
- Pregnant and lactating women
- Disagree with the survey or do not respond to the questionnaire
- Contraindications for each medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study
The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.
Read the detailed description
Purpose of Study>
- To evaluate the efficacy of tailored therapy compared to concomitant therapy.
- Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
- To evaluate the compliance of tailored therapy compared to concomitant.
- To analysis of factors which influence to the eradication rate.
Patients>
; Target disease
- peptic ulcers(gastric ulcer, duodenal ulcer),
- gastric MALToma,
- Endoscopic therapy state of early gastric cancer or gastric adenoma,
- Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.
Method>
Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lansoprazole 30mg, Amoxicillin 1.0g Tab, Clarithromycin 500mg, Metronidazole 500 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole 30mgDrug
Also called langton
lansoprazole 30 mg tablet
Amoxicillin 1.0g TabDrug
Also called amoxiclav
Amoxicillin 1.0g tablet
Clarithromycin 500mgDrug
Also called clavacin
Clarithromycin 500mg tablet
Metronidazole 500 mgDrug
Also called lysinyl
Metronidazole 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| concomitant group | Active comparator | lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation. Receives: Drug: Lansoprazole 30mg; Drug: Amoxicillin 1.0g Tab; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg |
| tailored treatment group I | Experimental | 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. Receives: Drug: Lansoprazole 30mg; Drug: Amoxicillin 1.0g Tab; Drug: Clarithromycin 500mg |
| tailored treatment group II | Experimental | 23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. Receives: Drug: Lansoprazole 30mg; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.
Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)
Measured: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks.
Secondary outcomes (1)
Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin
Identify the effect of 23S ribosomal RNA point mutation on the eradication rate regardless of the administration drug.
Measured: Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start17 Dec 2016
- Primary completion28 Jan 2019
- Study completion31 May 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Ji Hyun, Inje University
- Investigators
- Ji Hyun Kim, Principal investigator, Inje University Busan Paik hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130452
- Sponsor's protocol ID
- 2016-09-0025
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2017
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual patient data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03130452
- Acronym / sponsor ID
- 2016-09-0025
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Apr 2017 (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 compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.
Detailed description
Purpose of Study>
- To evaluate the efficacy of tailored therapy compared to concomitant therapy.
- Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
- To evaluate the compliance of tailored therapy compared to concomitant.
- To analysis of factors which influence to the eradication rate.
Patients>
; Target disease
- peptic ulcers(gastric ulcer, duodenal ulcer),
- gastric MALToma,
- Endoscopic therapy state of early gastric cancer or gastric adenoma,
- Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.
Method>
Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| concomitant group | Active comparator | Drug: Lansoprazole 30mg, Drug: Amoxicillin 1.0g Tab, Drug: Clarithromycin 500mg, Drug: Metronidazole 500 mglansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation. |
| tailored treatment group I | Experimental | Drug: Lansoprazole 30mg, Drug: Amoxicillin 1.0g Tab, Drug: Clarithromycin 500mg23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. |
| tailored treatment group II | Experimental | Drug: Lansoprazole 30mg, Drug: Clarithromycin 500mg, Drug: Metronidazole 500 mg23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- H. pylori infection diagnosed patient, between 18 years old and 80 years old
- No history of H. pylori eradication therapy
- No antibiotic use for more than 3 days within 1 month of treatment
Key exclusion criteria (6 listed)
- History of taking antibiotics for more than 3 days in the last 1 month
- History of subtotal or partial gastrectomy
- Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
- Pregnant and lactating women
- Disagree with the survey or do not respond to the questionnaire
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 |
|---|---|---|
| Lansoprazole 30mgAlso: langtonlansoprazole 30 mg tablet | Drug | concomitant group, tailored treatment group I, tailored treatment group II |
| Amoxicillin 1.0g TabAlso: amoxiclavAmoxicillin 1.0g tablet | Drug | concomitant group, tailored treatment group I |
| Clarithromycin 500mgAlso: clavacinClarithromycin 500mg tablet | Drug | concomitant group, tailored treatment group I, tailored treatment group II |
| Metronidazole 500 mgAlso: lysinylMetronidazole 500 mg tablet | Drug | concomitant group, tailored treatment group II |
Primary outcome
Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.
Time frame: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks.
Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)
1 secondary outcome
Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin
Time frame: Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed.
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 1 May 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual patient data available to other researchers.
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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.
Ji Hyun Kim principal investigator
Inje University Busan Paik hosipital
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 Lansoprazole 30mg, Amoxicillin 1.0g Tab and Clarithromycin 500mg in people with Helicobacter Pylori Infection, run by Inje University 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 3 inclusion and 6 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 1 May 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 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 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?
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?
Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy. (time frame: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 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 1 May 2025.