Clinical trial NCT03099876: A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited the hospital

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy
timeFrame: Day 49±5(or Day 52±5)
Secondary outcomes:
measure: The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.
timeFrame: Day 49±5(or Day 52±5)
measure: The eradication rate of H.pylori according to CYP polymorphism of patients.
timeFrame: Day 49±5(or Day 52±5)
measure: The eradication rate of H.pylori according to stage of disease of patients.
timeFrame: Day 49±5(or Day 52±5)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: The Catholic Univ. of Korea Daejeon St.Mary Hospital
city: Daejeon
country: Korea, Republic of
facility: The Chunngnam Univ. General Hospital
city: Daejeon
country: Korea, Republic of
facility: The Eulji Univ. General Hospital
city: Daejeon
country: Korea, Republic of
facility: The Konyang Univ. General Hospital
Study officials:
References: