Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori

Study Overview
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Brief Summary
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This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori

Detailed Description
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Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing

Conditions
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Helicobacter Pylori Eradication

Intervention / Treatment
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* Drug: Ilaprazole
* Drug: Esoprazole


Participation Criteria
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Eligibility Criteria
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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, Esoprazole, Amoxicillin and Clarithromycin 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 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 within 30 days Inconsistent judged subject by researcher

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole<br>Ilaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid. | Drug: Ilaprazole<br> <br> * Other names: Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid;|
| Active Comparator: Esoprazole<br>Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid. | Drug: Esoprazole<br> <br> * Other names: Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori as assessed by UBT test |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of side effects of each treatment |  | 2 months |