Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.

Detailed Description
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The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis. Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.

Official Title
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Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea

Conditions
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Helicobacter Infections

Intervention / Treatment
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* Drug: Ilaprazole + Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis. 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(Penicillin Antibiotics). 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 Uncontrolled kidney 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. Infectious mononucleosis patients Subjects participating in a clinical trial before another trial wihin 30 days Inconsistence judged subject by researcher

Ages Eligible for Study
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Minimum Age: 19 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole + Amoxicillin<br>Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days | Drug: Ilaprazole + Amoxicillin<br>* Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule<br>* Other names: Amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The eradication rate of H.pylori | The eradication rate of H.pylori after 14 days treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis. | Day 49±7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with Adverse Events |  | Day 49±7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helicobacter pylori, ilaprazole, eradication, dual therapy, high dose therapy