Gastritis, Gastric Ulcer, and Duodenal UlcerPhase 4NCT01922765
Concomitant Therapy of H. Pylori
A Phase 4 study testing amoxicillin, clarithromycin, metronidazole, rabeprazole in people with Gastritis, Gastric Ulcer, and Duodenal Ulcer, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastritis, Gastric Ulcer, and Duodenal Ulcer
- What is being tested?
- amoxicillin, clarithromycin, metronidazole, rabeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Feb 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients infected with Helicobacter pylori
Who cannot join
- cancer
- pregnancy
- formerly treated with eradication
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeouido St. Mary's Hospital
Seoul, 150-713
Jin Il Kim, MD,PhD, 82-10-6345-9977, jikim@catholic.ac.kr
Jin Il Kim, MD,PhD
About this study
Official title: Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.
Read the detailed description
- Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
- 170 subjects per group
- Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
- Being tested
- amoxicillin, clarithromycin, metronidazole, rabeprazole
- Keywords
- Helicobacter, Eradication
- Medical subject headings
- Gastritis, Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin, clarithromycin, metronidazole, rabeprazoleDrug
Also called AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days, AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days, Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days, concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
| Study group | Role | What they receive |
|---|---|---|
| AOC group | Experimental | AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days Receives: Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole |
| AOM group | Experimental | AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days Receives: Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole |
| Sequential group | Experimental | Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days Receives: Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole |
| concomitant group | Experimental | concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days Receives: Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment
Measured: 6 months (Feb 2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
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 Gastritis, Gastric Ulcer, and Duodenal UlcerStudies 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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Bucheon St. Mary's Hospital, St Vincent's Hospital
- Responsible party
- Principal investigator, Jin Il Kim, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922765
- Sponsor's protocol ID
- concomitant
- Status last verified
- Feb 2014
- First submitted
- 12 Aug 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee HJ, Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, Chung WC, Kim BW, Kim SS. Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol. 2015 Jan 7;21(1):351-9. doi: 10.3748/wjg.v21.i1.351.
PubMed 25574111
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT01922765
- Acronym / sponsor ID
- concomitant
- Keywords
- Helicobacter, Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Bucheon St. Mary's Hospital, St Vincent's Hospital
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 14 Aug 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.
If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.
Detailed description
- Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
- 170 subjects per group
- Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AOC group | Experimental | Drug: amoxicillin, clarithromycin, metronidazole, rabeprazoleAOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days |
| AOM group | Experimental | Drug: amoxicillin, clarithromycin, metronidazole, rabeprazoleAOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days |
| Sequential group | Experimental | Drug: amoxicillin, clarithromycin, metronidazole, rabeprazoleSequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days |
| concomitant group | Experimental | Drug: amoxicillin, clarithromycin, metronidazole, rabeprazoleconcomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients infected with Helicobacter pylori
Key exclusion criteria (3 listed)
- cancer
- pregnancy
- formerly treated with 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 |
|---|---|---|
| amoxicillin, clarithromycin, metronidazole, rabeprazoleAlso: AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days, AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days, Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days, concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days | Drug | AOC group, AOM group, Sequential group, concomitant group |
Primary outcome
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
Time frame: 6 months (Feb 2014)
measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Derived from this study: PubMed 25574111Lee HJ, Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, Chung WC, Kim BW, Kim SS. Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol. 2015 Jan 7;21(1):351-9. doi: 10.3748/wjg.v21.i1.351.
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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 amoxicillin, clarithromycin, metronidazole, rabeprazole in people with Gastritis, Gastric Ulcer, and Duodenal Ulcer, run by The Catholic University of 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 1 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 11 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori (time frame: 6 months (Feb 2014)). 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 NCT01922765, 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 11 Feb 2014.