UlcerPhase 4NCT00926809
H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection
A Phase 4 study testing Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin in people with Ulcer, run by Korean College of Helicobacter and Upper Gastrointestinal Research at 6 sites in South Korea.
Trial summary
This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Ulcer
- What is being tested?
- Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Sep 2008to Dec 2010
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 - 75 years old
- Early gastric cancer (< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (< 3 cm in size)
- Helicobacter pylori positive
Who cannot join
- Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
- History of Helicobacter pylori eradication
- History of gastric surgery or other cancers
- Major comorbidities
- Medication of ASA, NSAIDS, steroids, anti-coagulants
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
National Cancer Center Korea
Goyang
Il Ju Choi
- Recruiting
Asan Medical Center
Seoul
Ho June Song, hjsong@amc.seoul.kr
Hwoon-Yong Jung
- Recruiting
Korea University Hospital
Seoul
Hoon Jae Chun
- Recruiting
Seoul National University Hospital
Seoul
Sang Gyun Kim
Hyun Chae Jung
- Recruiting
Soonchunhyang University Hospital
Seoul
Joo Young Cho
- Recruiting
Yonsei University Severance Hospital
Seoul
Yong Chan Lee
Jae Hee Cheon
About this study
Official title: Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial
This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.
- Conditions
- Ulcer
- Being tested
- Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin, Lansoprazole (proton pump inhibitor), placebo
- Keywords
- endoscopic mucosal resection, iatrogenic
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycinDrug
Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
Lansoprazole (proton pump inhibitor), placeboDrug
Lansoprazole, Amoxicillin placebo, Clarythromycin placebo
| Study group | Role | What they receive |
|---|---|---|
| Eradication | Active comparator | Helicobacter pylori eradication Receives: Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin |
| No eradication | Placebo comparator | No eradication for Helicobacter pylori Receives: Drug: Lansoprazole (proton pump inhibitor), placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer healing rate by endoscopic assessment
Measured: 8 weeks
Secondary outcomes (1)
ulcer reduction rate by endoscopic assessment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean College of Helicobacter and Upper Gastrointestinal Research
- Sponsor type
- University, hospital or other
- Investigators
- Hyun Chae Jung, Principal investigator, Korean College of Helicobacter and Upper Gastrointestinal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926809
- Sponsor's protocol ID
- 2009KHR001
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00926809
- Acronym / sponsor ID
- 2009KHR001
- Conditions
- Ulcer
- Keywords
- endoscopic mucosal resection, iatrogenic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Korean College of Helicobacter and Upper Gastrointestinal ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 24 Jun 2009 (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.
This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eradication | Active comparator | Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycinHelicobacter pylori eradication |
| No eradication | Placebo comparator | Drug: Lansoprazole (proton pump inhibitor), placeboNo eradication for Helicobacter pylori |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30 - 75 years old
- Early gastric cancer (< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (< 3 cm in size)
- Helicobacter pylori positive
Key exclusion criteria (5 listed)
- Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
- History of Helicobacter pylori eradication
- History of gastric surgery or other cancers
- Major comorbidities
- Medication of ASA, NSAIDS, steroids, anti-coagulants
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 |
|---|---|---|
| Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycinLansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg | Drug | Eradication |
| Lansoprazole (proton pump inhibitor), placeboLansoprazole, Amoxicillin placebo, Clarythromycin placebo | Drug | No eradication |
Primary outcome
ulcer healing rate by endoscopic assessment
Time frame: 8 weeks
1 secondary outcome
ulcer reduction rate by endoscopic assessment
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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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.
Hyun Chae Jung principal investigator
Korean College of Helicobacter and Upper Gastrointestinal Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin in people with Ulcer, run by Korean College of Helicobacter and Upper Gastrointestinal Research at 6 sites 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 5 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 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 Ho June Song, Ph.D (82-2-3010-3916, hojunesong@yahoo.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ulcer healing rate by endoscopic assessment (time frame: 8 weeks). 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 25 Jun 2009.