Helicobacter Pylori InfectionPhase 4NCT01887249
15-day Sequential Therapy for Helicobacter Pylori Infection in Korea
A Phase 4 study testing Clarithromycin, metronidazole and esomeprazole in people with Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential… 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?
- Clarithromycin, metronidazole and esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Jul 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with H. pylori infection who had never received treatment for H. pylori infection
- H. pylori infection defined by a positive rapid urease test (CLOtest, Delta West, Bentley, Australia) by gastric mucosal biopsy from the lesser curvature of the mid antrum or mid body or histological evidence of H. pylori by modified Giemsa staining in the lesser and greater curvature of the mid antrum or mid body, respectively or a positive C-urea breath test.
Who cannot join
- Patients with concurrent critical illness, a history of previous upper gastrointestinal surgery, contraindication to any of the study medications, recent frequent intake of NSAIDs, anticoagulants or steroids, an allergy to the study medications, and those that were pregnant or breast-feeding women were excluded from the study. Other exclusion criteria include recent use of antimicrobials and any condition probably associated with poor compliance such as drug abusers or alcoholics.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Bundang-gu, Seongnam, Gyeonggi-do, 463-707
About this study
Official title: Randomized Clinical Trial: the Comparison of 15-day Sequential and 10-day Sequential Therapy to PPI-based Triple Therapy for Helicobacter Pylori Infection in Korea
10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with metronidazole was not ever tested before. Moreover, whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea. From this background, the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Clarithromycin, metronidazole, esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
metronidazoleDrug
esomeprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| 15 day sequential eradication therapy | Experimental | the 15-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for 10 days. Receives: Drug: Clarithromycin; Drug: metronidazole; Drug: esomeprazole |
| 10-day sequential eradication therapy | Active comparator | the 10-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five days Receives: Drug: Clarithromycin; Drug: metronidazole; Drug: esomeprazole |
| 7-day PPI triple eradication therapy | No intervention | 7-day PPI triple therapy regimen, which consisted of esomeprazole (40mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Measured: Four weeks after completing eradication therapy
Secondary outcomes (1)
Frequency and severity of side effects, Drug Compliance
Measured: Four weeks after completing eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionJul 2013
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 Seoul National University Bundang HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Republic of Korea (2012R1A1A3A04002680)
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887249
- Sponsor's protocol ID
- B-1007/106-001
- Status last verified
- Aug 2013
- First submitted
- 24 Jun 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: the Comparison of 15-day Sequential and 10-day Sequential Therapy to PPI-based Triple Therapy for Helicobacter Pylori Infection in Korea
- ClinicalTrials.gov ID
- NCT01887249
- Acronym / sponsor ID
- B-1007/106-001
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Ministry of Education, Republic of Korea (2012R1A1A3A04002680)
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jun 2013 (estimated)
- 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.
10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with metronidazole was not ever tested before. Moreover, whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea. From this background, the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 day sequential eradication therapy | Experimental | Drug: Clarithromycin, Drug: metronidazole, Drug: esomeprazolethe 15-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for 10 days. |
| 10-day sequential eradication therapy | Active comparator | Drug: Clarithromycin, Drug: metronidazole, Drug: esomeprazolethe 10-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five days |
| 7-day PPI triple eradication therapy | No intervention | –7-day PPI triple therapy regimen, which consisted of esomeprazole (40mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with H. pylori infection who had never received treatment for H. pylori infection
- H. pylori infection defined by a positive rapid urease test (CLOtest, Delta West, Bentley, Australia) by gastric mucosal biopsy from the lesser curvature of the mid antrum or mid body or histological evidence of H. pylori by modified Giemsa staining in the lesser and greater curvature of the mid antrum or mid body, respectively or a positive C-urea breath test.
Key exclusion criteria (1 listed)
- Patients with concurrent critical illness, a history of previous upper gastrointestinal surgery, contraindication to any of the study medications, recent frequent intake of NSAIDs, anticoagulants or steroids, an allergy to the study medications, and those that were pregnant or breast-feeding women were excluded from the study. Other exclusion criteria include recent use of antimicrobials and any condition probably associated with poor compliance such as drug abusers or alcoholics.
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 |
|---|---|---|
| Clarithromycin | Drug | 10-day sequential eradication therapy, 15 day sequential eradication therapy |
| metronidazole | Drug | 10-day sequential eradication therapy, 15 day sequential eradication therapy |
| esomeprazole | Drug | 10-day sequential eradication therapy, 15 day sequential eradication therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Four weeks after completing eradication therapy
1 secondary outcome
Frequency and severity of side effects, Drug Compliance
Time frame: Four weeks after completing eradication therapy
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 13 Aug 2013.
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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.
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 Phase 4 study testing Clarithromycin, metronidazole and esomeprazole 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 2 inclusion and 1 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 Aug 2013. 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?
Helicobacter pylori eradication rate (time frame: Four weeks after completing eradication therapy). 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 13 Aug 2013.