Helicobacter Pylori InfectionPhase 3NCT02557932
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
A Phase 3 study testing Standard triple therapy and Bismuth quadruple therapy in people with Helicobacter Pylori Infection and Family History of Stomach Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Family History of Stomach Cancer
- What is being tested?
- Standard triple therapy and Bismuth quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to 28 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or more including following conditions
- Family history of gastric cancer
- Post endoscopic resection status for early gastric cancer or adenoma
- Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
- Chronic gastritis
- Non-ulcer dyspepsia
- Healthy adults who want to receive H. pylori treatment
- H. pylori positive by urea breath test, histology, or rapid urease test
Who cannot join
- History of H. pylori eradication therapy
- History of stomach operation
- Other organ cancer within 5 years
- Liver cirrhosis or Hepatic insufficiency
- Renal insufficiency
- Current treatment for serious medical condition which may hinder participation
Show all 11Show fewer
- Contraindication or allergy history for H. pylori treatment regimens
- Mental incompetence to understand and sign informed consent
- Incompatible conditions to be included into the trial by investigators' decision
- Inability to provide an informed consent
- History of treatment for peptic ulcer disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.
Read the detailed description
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.
- Being tested
- Standard triple therapy, Bismuth quadruple therapy
- Keywords
- PPI standard triple therapy, Bismuth quadruple therapy, Helicobacter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard triple therapyDrug
Also called 7-day PPI-based standard triple therapy
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
Bismuth quadruple therapyDrug
Also called 10-day Bismuth quadruple therapy
Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Standard triple therapy | Active comparator | 7 day-PPI based standard triple therapy Receives: Drug: Standard triple therapy |
| Bismuth quadruple therapy | Active comparator | 10 day-bismuth quadruple therapy Receives: Drug: Bismuth quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Measured: 8 weeks after H. pylori treatment
Secondary outcomes (5)
Complications of H. pylori treatment
Measured: 1 month after H. pylori treatment
Compliance to H. pylori treatment
Measured: 1 month
H. pylori infection status at 1 year after H. pylori treatment
Measured: 1 year after H. pylori treatment
H. pylori reinfection rate
Measured: 3 years after success of H. pylori eradication
Factors associated with H. pylori reinfection
Measured: 3 years after success of H. pylori treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Il Ju Choi, National Cancer Center, Korea
- Investigators
- Il Ju Choi, M.D., Ph.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557932
- Sponsor's protocol ID
- NCC2015-0207
- Status last verified
- Apr 2020
- First submitted
- 21 Sep 2015
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.
PubMed 33653284
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02557932
- Acronym / sponsor ID
- NCC2015-0207
- Keywords
- PPI standard triple therapy, Bismuth quadruple therapy, Helicobacter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 23 Sep 2015 (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.
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.
Detailed description
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard triple therapy | Active comparator | Drug: Standard triple therapy7 day-PPI based standard triple therapy |
| Bismuth quadruple therapy | Active comparator | Drug: Bismuth quadruple therapy10 day-bismuth quadruple therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 18 or more including following conditions
- H. pylori positive by urea breath test, histology, or rapid urease test
Key exclusion criteria (11 listed)
- History of H. pylori eradication therapy
- History of stomach operation
- Other organ cancer within 5 years
- Liver cirrhosis or Hepatic insufficiency
- Renal insufficiency
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 |
|---|---|---|
| Standard triple therapyAlso: 7-day PPI-based standard triple therapyLansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days | Drug | Standard triple therapy |
| Bismuth quadruple therapyAlso: 10-day Bismuth quadruple therapyLansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days | Drug | Bismuth quadruple therapy |
Primary outcome
H. pylori eradication rate
Time frame: 8 weeks after H. pylori treatment
5 secondary outcomes
Complications of H. pylori treatment
Time frame: 1 month after H. pylori treatment
Compliance to H. pylori treatment
Time frame: 1 month
H. pylori infection status at 1 year after H. pylori treatment
Time frame: 1 year after H. pylori treatment
H. pylori reinfection rate
Time frame: 3 years after success of H. pylori eradication
Factors associated with H. pylori reinfection
Time frame: 3 years after success of H. pylori treatment
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 Apr 2020.
- Derived from this study: PubMed 33653284Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.
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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.
Il Ju Choi, M.D., Ph.D. principal investigator
National Cancer Center, Korea
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 Standard triple therapy and Bismuth quadruple therapy in people with Helicobacter Pylori Infection and Family History of Stomach Cancer, run by National Cancer Center, Korea 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 8 inclusion and 11 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 Apr 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: 8 weeks after H. pylori treatment). 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 NCT02557932, 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 8 Apr 2020.