Helicobacter Pylori InfectionNCT02159976
Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
A study testing Pantoprazole, Amoxicillin and Clarithromycin in people with Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea. 2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Pantoprazole, Amoxicillin and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Korean Adult (Aged ≥ 18 years)
- Patients who diagnosis of H. pylori infection by any of following three methods
- positive rapid urease test (CLOtest)
- histologic evidence of H. pylori by modified Giemsa staining
- positive 13C-urea breath test
Who cannot join
- Age under 18 years
- Previous eradication treatment for H. pylori
- Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
- History of gastrectomy
- Advanced gastric cancer or other malignancy
- Abnormal liver function or liver cirrhosis
Show all 10Show fewer
- Abnormal renal function or chronic kidney disease
- Other severe concurrent diseases
- Previous allergic reactions to the study drugs
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
- To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
- To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia
Read the detailed description
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Pantoprazole, Amoxicillin, Clarithromycin, Metronidazole, Tetracycline
- Keywords
- Helicobacter pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Pantoprazole 40mg bid
AmoxicillinDrug
Amoxicillin 1000mg bid
ClarithromycinDrug
Clarithromycin 500mg bid
MetronidazoleDrug
Metronidazole 500mg tid
TetracyclineDrug
Tetracycline 1000mg bid
BismuthDrug
Bismuth 600mg bid
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy | Active comparator | pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) Receives: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole |
| Modified bismuth quadruple therapy | Experimental | pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14) Receives: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Tetracycline; Drug: Bismuth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts of Participants With Successful H. Pylori Eradication
Measured: 4 weeks after termination of eradication therapy, up to 6 weeks
Secondary outcomes (3)
Counts of Participants Whose Drug Compliance is More Than 85%
Measured: 4 weeks after termination of eradication therapy, up to 6 weeks
Counts of Participants With Adverse Event
Measured: 4 weeks after termination of eradication therapy, up to 6 weeks
Functional Dyspepsia Symptom Responses Rate
Measured: 1 year after termination of eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd., Chong Kun Dang Pharmaceutical, HK inno.N Corporation, Green Cross Corporation
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159976
- Sponsor's protocol ID
- B-1403/243-003
- Status last verified
- Feb 2019
- First submitted
- 3 Jun 2014
- Last updated
- 13 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee JY, Kim N, Park KS, Kim HJ, Park SM, Baik GH, Shim KN, Oh JH, Choi SC, Kim SE, Kim WH, Park SY, Kim GH, Lee BE, Jo Y, Hong SJ. Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial. BMC Gastroenterol. 2016 Jul 26;16(1):79. doi: 10.1186/s12876-016-0490-8.
PubMed 27460100
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
- ClinicalTrials.gov ID
- NCT02159976
- Acronym / sponsor ID
- B-1403/243-003
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd., Chong Kun Dang Pharmaceutical, HK inno.N Corporation, Green Cross Corporation
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 13 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
- To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia
Detailed description
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy | Active comparator | Drug: Pantoprazole, Drug: Amoxicillin, Drug: Clarithromycin, Drug: Metronidazolepantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) |
| Modified bismuth quadruple therapy | Experimental | Drug: Pantoprazole, Drug: Amoxicillin, Drug: Tetracycline, Drug: Bismuthpantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female Korean Adult (Aged ≥ 18 years)
- Patients who diagnosis of H. pylori infection by any of following three methods
Key exclusion criteria (10 listed)
- Age under 18 years
- Previous eradication treatment for H. pylori
- Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
- History of gastrectomy
- Advanced gastric cancer or other malignancy
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 |
|---|---|---|
| PantoprazolePantoprazole 40mg bid | Drug | Modified bismuth quadruple therapy, Sequential therapy |
| AmoxicillinAmoxicillin 1000mg bid | Drug | Modified bismuth quadruple therapy, Sequential therapy |
| ClarithromycinClarithromycin 500mg bid | Drug | Sequential therapy |
| MetronidazoleMetronidazole 500mg tid | Drug | Sequential therapy |
| TetracyclineTetracycline 1000mg bid | Drug | Modified bismuth quadruple therapy |
| BismuthBismuth 600mg bid | Drug | Modified bismuth quadruple therapy |
Primary outcome
Counts of Participants With Successful H. Pylori Eradication
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
3 secondary outcomes
Counts of Participants Whose Drug Compliance is More Than 85%
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
Counts of Participants With Adverse Event
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
Functional Dyspepsia Symptom Responses Rate
Time frame: 1 year after termination of eradication therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27460100Lee JY, Kim N, Park KS, Kim HJ, Park SM, Baik GH, Shim KN, Oh JH, Choi SC, Kim SE, Kim WH, Park SY, Kim GH, Lee BE, Jo Y, Hong SJ. Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial. BMC Gastroenterol. 2016 Jul 26;16(1):79. doi: 10.1186/s12876-016-0490-8.
Related trials for Helicobacter Pylori Infection
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Active, not recruiting
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
Factors Affecting Helicobacter Pylori Infection: Diet and Lifestyle Patterns
Helicobacter Pylori Infection
Not yet recruiting
Bacillus Probiotics With Bismuth Quadruple Therapy for Helicobacter Pylori Infection
Helicobacter Pylori Infection, Gastrointestinal Dysbiosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantoprazole, Amoxicillin and Clarithromycin in people with Helicobacter Pylori Infection, run by Seoul National University Bundang 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 5 inclusion and 10 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 13 May 2019. 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?
Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Counts of Participants With Successful H. Pylori Eradication (time frame: 4 weeks after termination of eradication therapy, up to 6 weeks). 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 NCT02159976, 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 13 May 2019; AzTrials last refreshed its copy on 26 Oct 2026.