A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients

Study Overview
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Brief Summary
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The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.

Detailed Description
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This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for 7 days. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Official Title
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A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With CJ-12420, Amoxicillin and Clarithromycin in H. Pylori Positive Patients

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: CJ-12420/Clarithromycin/Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H. pylori-positive at screening Complain of gastric discomfort symptom Exclusion Criteria: Having received prior therapy for eradication of H. pylori Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-12420/Clarithromycin/Amoxicillin<br>CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g | Drug: CJ-12420/Clarithromycin/Amoxicillin<br>* CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days<br>* Other names: Lansoprazole/Clarithromycin/Amoxicillin;|
| Active Comparator: Lansoprazole/Clarithromycin/Amoxicillin<br>Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g | Drug: CJ-12420/Clarithromycin/Amoxicillin<br>* CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days<br>* Other names: Lansoprazole/Clarithromycin/Amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate | Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment) | twice a day |