Helicobacter Pylori InfectionNCT03099876
A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
An observational study of Helicobacter Pylori Infection, run by Il-Yang Pharm. Co., Ltd. at 4 sites in South Korea.
Trial summary
This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- treatment period
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Mar 2017to 1 Dec 2018
- How long will I take part?
- 7 Weeks
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited the hospital
Who may be able to join
- Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
- 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 and Levofloxacin
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Patients with abnormal levels in the laboratory tests Total Bilirubin, Creatinine> 1.5 times upper limit of normal AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal 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 13Show fewer
- Uncontrolled hypertension
- Uncontrolled liver dysfunction
- Alcoholics
- Subjects with a history 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.
- Subjects participating in a clinical trial before another trial wihin 30 days
- Inconsistence judged subject by researcher
Trial locations and contacts
4 sites in 1 country.
Dongsoo Lee contact
South Korea4 sites, 4 recruiting
- Recruiting
The Catholic Univ. of Korea Daejeon St.Mary Hospital
Daejeon
Dongsoo Lee, MD, PhD
- Not yet recruiting
The Chunngnam Univ. General Hospital
Daejeon
JaeKyu Sung, MD, PhD
- Not yet recruiting
The Eulji Univ. General Hospital
Daejeon
Sunghee Jung, MD, PhD
- Not yet recruiting
The Konyang Univ. General Hospital
Daejeon
Sunmoon Kim, MD, PhD
About this study
Official title: A Study on Eradication Rate of Triple Therapy Including Low Dose-PPI, Clarithromycin, Amoxicillin According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy
Read the detailed description
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- treatment period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment periodProcedure or surgery
7 days treatment or 10 days treatment
| Study group | Role | What they receive |
|---|---|---|
| 7 days treament group | 7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D) Receives: Procedure: treatment period | |
| 10 days treatment group | 10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D) Receives: Procedure: treatment period |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy
The eradication rate of H.pylori after 7 days(or 10 days) treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy or UBT test. The treatment : Noltec(Ilaprazole) 10mg+Pamoxine Cap(Amoxicillin) 1000mg+Clafaxine(Clarithromycin) 500mg was administered twice a day for 7days(or 10days)
Measured: Day 49±5(or Day 52±5)
Secondary outcomes (3)
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.
Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.
Measured: Day 49±5(or Day 52±5)
The eradication rate of H.pylori according to CYP polymorphism of patients.
The eradication rate of H.pylori is analyzed accroding to CYP polymorphism: CYP2C19 homo EM, hetero EM, PM
Measured: Day 49±5(or Day 52±5)
The eradication rate of H.pylori according to stage of disease of patients.
The eradication rate of H.pylori is analyzed accroding to stage of disease: active stage, healing stage, scar stage, gastritis.
Measured: Day 49±5(or Day 52±5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 7 Weeks
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, IL-YANG RA, Il-Yang Pharm. Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099876
- Sponsor's protocol ID
- CMC-LDS-ILA02
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Eradication Rate of Triple Therapy Including Low Dose-PPI, Clarithromycin, Amoxicillin According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
- ClinicalTrials.gov ID
- NCT03099876
- Acronym / sponsor ID
- CMC-LDS-ILA02
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 4 Apr 2017 (actual)
- 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 compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy
Detailed description
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 days treament group | – | Procedure: treatment period7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D) |
| 10 days treatment group | – | Procedure: treatment period10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the hospital
Key inclusion criteria (3 listed)
- Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
- Subject who fully understands conditions of clinical trial.
- Subject who agrees to participate and spontaneously sign the ICF
Key exclusion criteria (13 listed)
- Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Patients with abnormal levels in the laboratory tests Total Bilirubin, Creatinine> 1.5 times upper limit of normal AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal 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 |
|---|---|---|
| treatment period7 days treatment or 10 days treatment | Procedure or surgery | 10 days treatment group, 7 days treament group |
Primary outcome
The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy
Time frame: Day 49±5(or Day 52±5)
The eradication rate of H.pylori after 7 days(or 10 days) treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy or UBT test. The treatment : Noltec(Ilaprazole) 10mg+Pamoxine Cap(Amoxicillin) 1000mg+Clafaxine(Clarithromycin) 500mg was administered twice a day for 7days(or 10days)
3 secondary outcomes
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.
Time frame: Day 49±5(or Day 52±5)
The eradication rate of H.pylori according to CYP polymorphism of patients.
Time frame: Day 49±5(or Day 52±5)
The eradication rate of H.pylori according to stage of disease of patients.
Time frame: Day 49±5(or Day 52±5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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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.
Dongsoo Lee contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Il-Yang Pharm. Co., Ltd. at 4 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 13 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Dongsoo Lee (endoscope@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy (time frame: Day 49±5(or Day 52±5)). 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 7 Apr 2017.