The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

Study Overview
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Brief Summary
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This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.

Detailed Description
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This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients. The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody. The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment

Official Title
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The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: Ilaprazole
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 20 year old ≤ Male or female < 80 year old Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test. Subject who fully understands conditions of clinical trial Subject who agrees to participate and spontaneously sign the ICF Exclusion Criteria: Known hypersensitivity to experimental and concomitant drugs Subjects who are taking contraindicated medications for experimental and concomitant drug. Subjects 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 2 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 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 Subjects participating in a clinical trial before another trial within 30 days Inconsistence judged subject by researcher

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: triple with clarithromycin<br>Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks | Drug: Ilaprazole<br>* Ilaprazole 10mg 1tablet qid(4 times/day)<br>* Other names: Noltec®;Drug: Amoxicillin<br>* Amoxicillin 500mg 1capsule qid(4times/day)<br>* Other names: Pamoxin®;Drug: Clarithromycin<br>* Clarithromycin 500mg 1tablet bid(2times/day)<br>* Other names: Clafaxin®;|
| Experimental: triple with metronidazole<br>Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks | Drug: Ilaprazole<br>* Ilaprazole 10mg 1tablet qid(4 times/day)<br>* Other names: Noltec®;Drug: Amoxicillin<br>* Amoxicillin 500mg 1capsule qid(4times/day)<br>* Other names: Pamoxin®;Drug: Metronidazole<br>* Metronidazole 250mg 2tablets tid(3times/day)<br>* Other names: Flasinyl®;|
| Experimental: quadruple<br>Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks | Drug: Ilaprazole<br>* Ilaprazole 10mg 1tablet qid(4 times/day)<br>* Other names: Noltec®;Drug: Amoxicillin<br>* Amoxicillin 500mg 1capsule qid(4times/day)<br>* Other names: Pamoxin®;Drug: Clarithromycin<br>* Clarithromycin 500mg 1tablet bid(2times/day)<br>* Other names: Clafaxin®;Drug: Metronidazole<br>* Metronidazole 250mg 2tablets tid(3times/day)<br>* Other names: Flasinyl®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate after tailored therapy assessed by urea breath test | After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT. | Test at 4 -6 weeks after completion of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by questionnaire | During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire. | Questionnaire and diary during medication for 14days |