A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
NCT ID: NCT03099876
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
320 participants
OBSERVATIONAL
2017-03-01
2018-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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7 days treament group
7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)
treatment period
7 days treatment or 10 days treatment
10 days treatment group
10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)
treatment period
7 days treatment or 10 days treatment
Interventions
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treatment period
7 days treatment or 10 days treatment
Eligibility Criteria
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Inclusion Criteria
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF
Exclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Il-Yang Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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IL-YANG RA
Il-Yang Pharm. Co., Ltd.
Locations
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The Catholic Univ. of Korea Daejeon St.Mary Hospital
Daejeon, , South Korea
The Chunngnam Univ. General Hospital
Daejeon, , South Korea
The Eulji Univ. General Hospital
Daejeon, , South Korea
The Konyang Univ. General Hospital
Daejeon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Dongsoo Lee, MD, PhD
Role: primary
JaeKyu Sung, MD, PhD
Role: primary
Sunghee Jung, MD, PhD
Role: primary
Sunmoon Kim, MD, PhD
Role: primary
Other Identifiers
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CMC-LDS-ILA02
Identifier Type: -
Identifier Source: org_study_id
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