Helicobacter Pylori InfectionPhase 4NCT03665428
Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea
A Phase 4 study testing PAMB treatment (modified quadruple therapy) and PBMT treatment (bismuth-containing quadruple therapy) in people with Helicobacter Pylori Infection, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- PAMB treatment (modified quadruple therapy) and PBMT treatment (bismuth-containing quadruple therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jul 2018to 31 Dec 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.
- Participants who voluntarily want to participate in this study.
Who cannot join
- Participants who had history of Helicobacter pylori eradication.
- Participants who had experience of stomach resection.
- Participants who had history of allergy or adverse events related to eradication medication.
- Participants who had history of administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.
- Participants who had history of administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate
- Participants who had history of administration of antibiotics within 4 weeks.
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- Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial
- Participants who are administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor)
- Participants who have infectious mononucleosis, central nervous system infection, hematologic disease, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, Torsades de pointes.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart hospital
Chuncheon, Gangwon-do, 24253
About this study
Official title: Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea; Open-label, Randomized Controlled Trial
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
Read the detailed description
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, this study did not explore the antibiotic resistance profile of Helicobacter pylori. And, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- PAMB treatment (modified quadruple therapy), PBMT treatment (bismuth-containing quadruple therapy)
- Keywords
- helicobacter pylori infection, Drug Resistance, Microbial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMB treatment (modified quadruple therapy)Drug
Also called PBMT treatment (bismuth-containing quadruple therapy)
Randomly assign either as PAMB or PBMT group treatment
PBMT treatment (bismuth-containing quadruple therapy)Drug
Also called PAMB treatment (modified quadruple therapy)
Randomly assign either as PAMB or PBMT group treatment
| Study group | Role | What they receive |
|---|---|---|
| PAMB group | Experimental | PAMB treatment (modified quadruple therapy) for 14 days Receives: Drug: PAMB treatment (modified quadruple therapy) |
| PMBT group | Active comparator | PBMT treatment (bismuth-containing quadruple therapy) for 14 days Receives: Drug: PBMT treatment (bismuth-containing quadruple therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eradication success
Eradication success means negative urea breath test done at least after 4 weeks from medication administration
Measured: up to 4 weeks
Secondary outcomes (2)
Rate of adverse events related to eradication medication
Adverse events related to eradication medication
Measured: up to 4 weeks
Rate of compliance of eradication medication administration
Compliance (percentage of amount) of eradication medication administration
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start16 Jul 2018
- Primary completion6 Aug 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.
- 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
- Model description
- PAMB group (modified quadruple therapy) vs. PBMT group (bismuth-containing quadruple therapy)
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Medical Center
- Responsible party
- Principal investigator, Chang Seok Bang, Chuncheon Sacred Heart Hospital
- Investigators
- Chang Seok Bang, MD, PhD, Principal investigator, Hallym University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665428
- Sponsor's protocol ID
- CSBang2018HP
- Status last verified
- May 2020
- First submitted
- 25 Jun 2018
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea; Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03665428
- Acronym / sponsor ID
- CSBang2018HP
- Conditions
- Helicobacter Pylori Infection
- Keywords
- helicobacter pylori infection, Drug Resistance, Microbial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University Medical Center
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Sep 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.
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
Detailed description
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, this study did not explore the antibiotic resistance profile of Helicobacter pylori. And, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PAMB group (modified quadruple therapy) vs. PBMT group (bismuth-containing quadruple therapy)
| Arm | Type | Receives |
|---|---|---|
| PAMB group | Experimental | Drug: PAMB treatment (modified quadruple therapy)PAMB treatment (modified quadruple therapy) for 14 days |
| PMBT group | Active comparator | Drug: PBMT treatment (bismuth-containing quadruple therapy)PBMT treatment (bismuth-containing quadruple therapy) for 14 days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.
- Participants who voluntarily want to participate in this study.
Key exclusion criteria (9 listed)
- Participants who had history of Helicobacter pylori eradication.
- Participants who had experience of stomach resection.
- Participants who had history of allergy or adverse events related to eradication medication.
- Participants who had history of administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.
- Participants who had history of administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate
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 |
|---|---|---|
| PAMB treatment (modified quadruple therapy)Also: PBMT treatment (bismuth-containing quadruple therapy)Randomly assign either as PAMB or PBMT group treatment | Drug | PAMB group |
| PBMT treatment (bismuth-containing quadruple therapy)Also: PAMB treatment (modified quadruple therapy)Randomly assign either as PAMB or PBMT group treatment | Drug | PMBT group |
Primary outcome
Rate of eradication success
Time frame: up to 4 weeks
Eradication success means negative urea breath test done at least after 4 weeks from medication administration
2 secondary outcomes
Rate of adverse events related to eradication medication
Time frame: up to 4 weeks
Rate of compliance of eradication medication administration
Time frame: up to 4 weeks
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 21 May 2020.
- 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.
Chang Seok Bang, MD, PhD principal investigator
Hallym University
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 PAMB treatment (modified quadruple therapy) and PBMT treatment (bismuth-containing quadruple therapy) in people with Helicobacter Pylori Infection, run by Chuncheon Sacred Heart 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 9 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 21 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 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?
Rate of eradication success (time frame: up to 4 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 21 May 2020.