Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.

Detailed Description
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This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.

Official Title
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PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: Ilaprazole
* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 year old ≤ Male or female < 75 year old Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test Patients who understand the study conditions Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud Exclusion Criteria: Patients with known allergy or hypersensitivity reaction to the Investigational products Patients who use the Investigational products Patients who undergone H.pylori eradication Patients with abnormal laboratory results, as specified below: Total bilirubin, creatinine > 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen > 2 x upper limit of normal Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products Pregnant women and lactating women Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile) Patients with uncontrolled Diabetes mellitus Patients with uncontrolled Hypertension Patients with Alcoholics Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin) Patients who had undergone a esophageal or gastric surgery Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption Patients who had participated in other investigational study within 30 days before the study entry (Day 1) Patients who, in the investigator's opinion, are not suitable for the study for any other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole or Pantoprazole placebo<br>Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO | Drug: Ilaprazole<br>* 10mg 2 BID( 2 times / day), before breakfast and dinner<br>* Other names: NOLTEC;|
| Active Comparator: Ilaprazole placebo or Pantoprazole<br>Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO | Drug: Pantoprazole<br>* 40mg, BID(2 times / day), before breakfast and dinner<br>* Other names: PANTOLOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of H.pylori eradication |  | participants will be followed at 7 weeks (visit 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of Gastric and/or Duodenal ulcer curation |  | participants will be followed at 7 weeks (visit 4) |