Helicobacter Infected PatientsPhase 4NCT01418300
Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial
A Phase 4 study testing sequential versus triple in people with Helicobacter Infected Patients, run by Jun-Won Chung at 1 site in South Korea.
Trial summary
The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Infected Patients
- What is being tested?
- sequential versus triple
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Dec 2011
- 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 diseae
- two test positive rapid urease test, culture, histology
Who cannot join
- lactating or pregnant
- previous stomach surgery
- severe underlying disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.
- Conditions
- Helicobacter Infected Patients
- Being tested
- sequential versus triple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential versus tripleDrug
sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid
| Study group | Role | What they receive |
|---|---|---|
| sequential therapy | Active comparator | first five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole Receives: Drug: sequential versus triple |
| conventional triple thearpy | Active comparator | PPI+amoxicillin+clarithromycin Receives: Drug: sequential versus triple |
What is being measured
The primary outcome is the main question the study is designed to answer.
the eradication rate by urea breath test
to compare the eradication rate (intention-to-treat and per protocol) by urea breath test at least four weeks after treatment
Measured: 4-6 week later after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Infected PatientsStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun-Won Chung
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Jun-Won Chung, Jeil Pharmacy Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418300
- Sponsor's protocol ID
- GMC2010-088
- Status last verified
- Aug 2011
- First submitted
- 13 Aug 2011
- Last updated
- 28 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01418300
- Acronym / sponsor ID
- GMC2010-088
- Conditions
- Helicobacter Infected Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Jun-Won ChungIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Aug 2011 (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.
The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential therapy | Active comparator | Drug: sequential versus triplefirst five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole |
| conventional triple thearpy | Active comparator | Drug: sequential versus triplePPI+amoxicillin+clarithromycin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- peptic ulcer diseae
- two test positive rapid urease test, culture, histology
Key exclusion criteria (3 listed)
- lactating or pregnant
- previous stomach surgery
- severe underlying disease
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 versus triplesequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid | Drug | conventional triple thearpy, sequential therapy |
Primary outcome
the eradication rate by urea breath test
Time frame: 4-6 week later after completion of therapy
to compare the eradication rate (intention-to-treat and per protocol) by urea breath test at least four weeks after 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 28 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 versus triple in people with Helicobacter Infected Patients, run by Jun-Won Chung 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 2 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: finished, as of the sponsor's last update on 28 Apr 2015. 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 eradication rate by urea breath test (time frame: 4-6 week later after completion of therapy). 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 28 Apr 2015.