Helicobacter EradicationPhase 4NCT01938534
Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use
A Phase 4 study testing Helicobacter pylori eradication in people with Helicobacter Eradication, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Eradication
- What is being tested?
- Helicobacter pylori eradication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peptic ulcer disease
- Gastric MALT lymphoma
- Early gastric cancer
- Familial history of gastric cancer
- Idiopathic iron deficiency
- Chronic idiopathic thrombocytopenia
Show all 9Show fewer
- Atrophic gastritis
- Helicobacter infected dyspepsia
- Long term NSAIDs use
Who cannot join
- Pregnant
- Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
- Previous stomach surgery
- Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
- Previous Helicobacter eradication
- Allergy for Helicobacter eradication medicine
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, 443-721
Kee Myung Lee, M.D., Ph.D., 82-31-219-6939, lkm5104@ajou.ac.kr
Sun Gyo Lim, M.D., 82-31-219-6939, mdlsk75@hanmail.net
About this study
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.
Read the detailed description
Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.
- Conditions
- Helicobacter Eradication
- Being tested
- Helicobacter pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter pylori eradicationDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice
for 10 days Receives: Drug: Helicobacter pylori eradication |
| Control | Active comparator | Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days Receives: Drug: Helicobacter pylori eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter EradicationStudies 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Gyo Lim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938534
- Sponsor's protocol ID
- AJOU-EIRB-152692
- Status last verified
- Dec 2013
- First submitted
- 5 Sep 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use
- ClinicalTrials.gov ID
- NCT01938534
- Acronym / sponsor ID
- AJOU-EIRB-152692
- Conditions
- Helicobacter Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 10 Sep 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.
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.
Detailed description
Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Helicobacter pylori eradicationOmeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days |
| Control | Active comparator | Drug: Helicobacter pylori eradicationTetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Peptic ulcer disease
- Gastric MALT lymphoma
- Early gastric cancer
- Familial history of gastric cancer
- Idiopathic iron deficiency
Key exclusion criteria (6 listed)
- Pregnant
- Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
- Previous stomach surgery
- Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
- Previous Helicobacter eradication
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 |
|---|---|---|
| Helicobacter pylori eradication | Drug | Control, Experimental |
Primary outcome
Eradication rate of Helicobacter pylori
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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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 Helicobacter pylori eradication in people with Helicobacter Eradication, run by Ajou University School of Medicine 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 9 inclusion and 6 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 1 Jan 2014. 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 Ki Myung Lee, M.D., Ph.D. (82-31-219-6939, lkm5104@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori (time frame: one month). 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 1 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.