Triple Therapy With Tegoprazan in H. Pylori Positive Patients

Study Overview
=================
Brief Summary
-----------------
The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.

Detailed Description
-----------------
This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

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

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Tegoprazan/Amoxicillin/Clarithromycin
* Drug: Lansoprazole/Amoxicillin/Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: H. pylori positive based on the screening test Peptic ulcer disease Exclusion Criteria: Prior treatment for H. pylori eradication 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
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegoprazan/Amoxicillin/Clarithromycin<br>Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg | Drug: Tegoprazan/Amoxicillin/Clarithromycin<br>* Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.<br>* Other names: Tegoprazan triple therapy (TAC);|
| Active Comparator: Lansoprazole/Amoxicillin/Clarithromycin<br>Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg | Drug: Lansoprazole/Amoxicillin/Clarithromycin<br>* Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.<br>* Other names: Lansoprazole triple therapy (LAC);|

What is the study measuring?
-----------------
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 subjects's negative UBT test. | 6 weeks |