H.Pylori Gastrointestinal DiseasePhase 4NCT02487511
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
A Phase 4 study testing Duration of HP therapy in people with H.Pylori Gastrointestinal Disease, run by St.Paul's Hospital, Korea at 1 site in South Korea.
Trial summary
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- H.Pylori Gastrointestinal Disease
- What is being tested?
- Duration of HP therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2015to 31 Jan 2017
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peptic ulcer including ulcer scar
- Early gastric cancer
- Gastric mucosa-associated lymphoid tissue lymphoma
Who cannot join
- operation history
- liver cirrhosis
- chronic kidney disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.
This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.
Read the detailed description
The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.
The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).
- Conditions
- H.Pylori Gastrointestinal Disease
- Being tested
- Duration of HP therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of HP therapyOther
the comparison of HP eradication rate between 7 days and 14 days
| Study group | Role | What they receive |
|---|---|---|
| 14 days | Active comparator | 14 days treatment regimen Receives: Other: Duration of HP therapy |
| 7 days | No intervention | 7 days treatment regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the comparison with 7days and 14days eradication rate of PPI based therapy
Measured: 12 months after randomization
Secondary outcomes (1)
the rate of side effects related to helicobacter eradication regimen
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Aug 2016
- Study completion31 Jan 2017
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 H.Pylori Gastrointestinal DiseaseStudies 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
- None (open label)
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- St.Paul's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JUNG HWAN OH, St.Paul's Hospital, Korea
- Investigators
- JUNG HWAN Oh, MD, PhD, Principal investigator, the Catholic Univerisity of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487511
- Sponsor's protocol ID
- HPTX Duration
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2015
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim TH, Park JM, Cheung DY, Oh JH. Comparison of 7- and 14-Day Eradication Therapy for Helicobacter pylori with First- and Second-Line Regimen: Randomized Clinical Trial. J Korean Med Sci. 2020 Feb 10;35(5):e33. doi: 10.3346/jkms.2020.35.e33.
PubMed 32030921
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT02487511
- Acronym / sponsor ID
- HPTX Duration
- Conditions
- H.Pylori Gastrointestinal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- St.Paul's Hospital, KoreaUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 1 Jul 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.
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.
This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.
Detailed description
The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.
The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14 days | Active comparator | Other: Duration of HP therapy14 days treatment regimen |
| 7 days | No intervention | –7 days treatment regimen |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peptic ulcer including ulcer scar
- Early gastric cancer
- Gastric mucosa-associated lymphoid tissue lymphoma
Key exclusion criteria (4 listed)
- operation history
- liver cirrhosis
- chronic kidney disease
- pregnancy
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 |
|---|---|---|
| Duration of HP therapythe comparison of HP eradication rate between 7 days and 14 days | Other | 14 days |
Primary outcome
the comparison with 7days and 14days eradication rate of PPI based therapy
Time frame: 12 months after randomization
1 secondary outcome
the rate of side effects related to helicobacter eradication regimen
Time frame: 12 months after randomization
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 9 Jun 2017.
- Derived from this study: PubMed 32030921Kim TH, Park JM, Cheung DY, Oh JH. Comparison of 7- and 14-Day Eradication Therapy for Helicobacter pylori with First- and Second-Line Regimen: Randomized Clinical Trial. J Korean Med Sci. 2020 Feb 10;35(5):e33. doi: 10.3346/jkms.2020.35.e33.
- 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.
JUNG HWAN Oh, MD, PhD principal investigator
the Catholic Univerisity of Korea
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 Duration of HP therapy in people with H.Pylori Gastrointestinal Disease, run by St.Paul's Hospital, 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 3 inclusion and 4 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 9 Jun 2017. 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?
the comparison with 7days and 14days eradication rate of PPI based therapy (time frame: 12 months after randomization). 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 NCT02487511, 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 9 Jun 2017.