Helicobacter InfectionsPhase 4NCT02401477
Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection
A Phase 4 study testing Ilaprazole + Amoxicillin in people with Helicobacter Infections, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Ilaprazole + Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Jun 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.
- Subject who fully understands conditions of clinical trial.
- Subject who agrees to participate and spontaneously sign the ICF
Who cannot join
- Known hypersensitivity to any component of Ilaprazole, Amoxicillin(Penicillin Antibiotics).
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
- Pregnant and/or lactating women
- Reproductive aged women not using contraception
- Uncontrolled diabetics
Show all 16Show fewer
- Uncontrolled hypertension
- Uncontrolled liver dysfunction
- Uncontrolled kidney dysfunction
- Alcoholics
- Subjects with a history or possibility of digestive malignancy within 5 years
- Subjects with a history of gastrectomy or esophagectomy
- Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption.
- Infectious mononucleosis patients
- Subjects participating in a clinical trial before another trial wihin 30 days
- Inconsistence judged subject by researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do
About this study
Official title: Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea
This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.
Read the detailed description
The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.
Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.
- Conditions
- Helicobacter Infections
- Being tested
- Ilaprazole + Amoxicillin
- Keywords
- helicobacter pylori, ilaprazole, eradication, dual therapy, high dose therapy
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilaprazole + AmoxicillinDrug
Also called Ilaprazole, Amoxicillin
Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole + Amoxicillin | Experimental | Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days Receives: Drug: Ilaprazole + Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of H.pylori
The eradication rate of H.pylori after 14 days treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.
Measured: Day 49±7
Secondary outcomes (1)
The number of patients with Adverse Events
Measured: Day 49±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YoonJeong Lim, MD, PhD, Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401477
- Sponsor's protocol ID
- DUMC-LYJ-ILA01
- Status last verified
- Nov 2015
- First submitted
- 24 Mar 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea
- ClinicalTrials.gov ID
- NCT02401477
- Acronym / sponsor ID
- DUMC-LYJ-ILA01
- Conditions
- Helicobacter Infections
- Keywords
- helicobacter pylori, ilaprazole, eradication, dual therapy, high dose therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Mar 2015 (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 assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.
Detailed description
The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.
Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ilaprazole + Amoxicillin | Experimental | Drug: Ilaprazole + AmoxicillinNoltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.
- Subject who fully understands conditions of clinical trial.
- Subject who agrees to participate and spontaneously sign the ICF
Key exclusion criteria (16 listed)
- Known hypersensitivity to any component of Ilaprazole, Amoxicillin(Penicillin Antibiotics).
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
- Pregnant and/or lactating women
- Reproductive aged women not using contraception
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 |
|---|---|---|
| Ilaprazole + AmoxicillinAlso: Ilaprazole, AmoxicillinIlaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule | Drug | Ilaprazole + Amoxicillin |
Primary outcome
The eradication rate of H.pylori
Time frame: Day 49±7
The eradication rate of H.pylori after 14 days treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.
1 secondary outcome
The number of patients with Adverse Events
Time frame: Day 49±7
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 3 Nov 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.
YoonJeong Lim, MD, PhD principal investigator
DongGuk University
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 Ilaprazole + Amoxicillin in people with Helicobacter Infections, run by Il-Yang Pharm. Co., Ltd. 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 3 inclusion and 16 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 3 Nov 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 of H.pylori (time frame: Day 49±7). 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 3 Nov 2015.