Helicobacter Pylori InfectionPhase 4NCT02108184
Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
A Phase 4 study testing Sequential therapy 10 days, Sequential therapy 14 days and Concomitant therapy 10 days in people with Helicobacter Pylori Infection, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. single center, randomized trial 1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days 2. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Sequential therapy 10 days, Sequential therapy 14 days and Concomitant therapy 10 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Aug 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20~80 patients
- agreement of informed consent
- H.pylori positive (biopsy, CLO)
- Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer
Who cannot join
- H.pylori eradication history
- severe hepatic, renal, cardiac failure
- pregnancy, participant of other study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Incheon St.Mary hospital
Incheon, Bupyung, KSXX0009
Sungmin Park
About this study
Official title: Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
single center, randomized trial
Read more
- (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
- (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
- (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
- (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days
1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Sequential therapy 10 days, Sequential therapy 14 days, Concomitant therapy 10 days, Concomitant therapy 14 days
- Keywords
- helicobacter eradication rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential therapy 10 daysDrug
(pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg ) bid for the next 5 days : Sequential therapy 1
Sequential therapy 14 daysDrug
(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days : Sequential therpay 2
Concomitant therapy 10 daysDrug
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1
Concomitant therapy 14 daysDrug
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy 10 days | Experimental | 1.(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 5 days Receives: Drug: Sequential therapy 10 days |
| Sequential therapy 14 days | Active comparator | (pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days Receives: Drug: Sequential therapy 14 days |
| Concomitant therapy 10 days | Active comparator | (pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days Receives: Drug: Concomitant therapy 10 days |
| Concomitant therapy 14 days | Active comparator | (pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days Receives: Drug: Concomitant therapy 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
To assess Helicobacter pylori eradication rates
Measured: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung min, Park, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108184
- Sponsor's protocol ID
- PSungmin
- Status last verified
- Feb 2016
- First submitted
- 26 Feb 2014
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lim JH, Lee DH, Choi C, Lee ST, Kim N, Jeong SH, Kim JW, Hwang JH, Park YS, Lee SH, Shin CM, Jo HJ, Jang ES, Song Is, Jung HC. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study. Helicobacter. 2013 Jun;18(3):180-6. doi: 10.1111/hel.12034. Epub 2013 Jan 11.
PubMed 23305083Kim JS, Kim BW, Ham JH, Park HW, Kim YK, Lee MY, Ji JS, Lee BI, Choi H. Sequential Therapy for Helicobacter pylori Infection in Korea: Systematic Review and Meta-Analysis. Gut Liver. 2013 Sep;7(5):546-51. doi: 10.5009/gnl.2013.7.5.546. Epub 2013 Aug 14.
PubMed 24073312
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea
- ClinicalTrials.gov ID
- NCT02108184
- Acronym / sponsor ID
- PSungmin
- Conditions
- Helicobacter Pylori Infection
- Keywords
- helicobacter eradication rates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Apr 2014 (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.
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
single center, randomized trial
- (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
- (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
- (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
- (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days
1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy 10 days | Experimental | Drug: Sequential therapy 10 days1.(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 5 days |
| Sequential therapy 14 days | Active comparator | Drug: Sequential therapy 14 days(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days |
| Concomitant therapy 10 days | Active comparator | Drug: Concomitant therapy 10 days(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days |
| Concomitant therapy 14 days | Active comparator | Drug: Concomitant therapy 14 days(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20~80 patients
- agreement of informed consent
- H.pylori positive (biopsy, CLO)
- Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer
Key exclusion criteria (3 listed)
- H.pylori eradication history
- severe hepatic, renal, cardiac failure
- pregnancy, participant of other study
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 |
|---|---|---|
| Sequential therapy 10 days(pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg ) bid for the next 5 days : Sequential therapy 1 | Drug | Sequential therapy 10 days |
| Sequential therapy 14 days(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days : Sequential therpay 2 | Drug | Sequential therapy 14 days |
| Concomitant therapy 10 days(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1 | Drug | Concomitant therapy 10 days |
| Concomitant therapy 14 days(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2 | Drug | Concomitant therapy 14 days |
Primary outcome
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
Time frame: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit
To assess Helicobacter pylori eradication rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Background: PubMed 23305083Lim JH, Lee DH, Choi C, Lee ST, Kim N, Jeong SH, Kim JW, Hwang JH, Park YS, Lee SH, Shin CM, Jo HJ, Jang ES, Song Is, Jung HC. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study. Helicobacter. 2013 Jun;18(3):180-6. doi: 10.1111/hel.12034. Epub 2013 Jan 11.
- Results publication: PubMed 24073312Kim JS, Kim BW, Ham JH, Park HW, Kim YK, Lee MY, Ji JS, Lee BI, Choi H. Sequential Therapy for Helicobacter pylori Infection in Korea: Systematic Review and Meta-Analysis. Gut Liver. 2013 Sep;7(5):546-51. doi: 10.5009/gnl.2013.7.5.546. Epub 2013 Aug 14.
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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.
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 Sequential therapy 10 days, Sequential therapy 14 days and Concomitant therapy 10 days in people with Helicobacter Pylori Infection, run by Incheon St.Mary's 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung min Park (082-032-280-5052, danson2000@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. (time frame: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit). 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 NCT02108184, which also lists 2 linked publications.
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 25 Feb 2016.