To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient

Study Overview
=================
Brief Summary
-----------------
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients with Gastritis

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients With Gastritis

Conditions
-----------------
Gastritis Acute, Gastritis Chronic

Intervention / Treatment
-----------------
* Drug: DW1903
* Drug: DW1903-R1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial. At least one or more erosions have been identified on gastroscopy. Patients who decided to voluntarily participate in this trial and agreed in writing. Exclusion Criteria: Patients who can not undergo gastroscopy Peptic ulcer (except scarring) and reflux esophagitis Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy) Patients with a history of gastrointestinal malignancies Zollinger-Ellison syndrome patients Patient with spontaneous coagulation disorder Patients with an allergic or hypersensitive response to a study drug Patients with a potential pregnancy. Patients who had clinically significant abnormalities in the screening test. Pregnant and lactating women Those currently taking other study drugs patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DW1903(Test)<br>once a day, q.d. PO / DW1903 + Placebo of DW1903-R1 | Drug: DW1903<br>* q.d. PO, DW1903 + Placebo of DW1903-R1<br>|
| Active Comparator: DW1903-R1(Reference)<br>once a day, q.d. PO / Placebo of DW1903 + DW1903-R1 | Drug: DW1903-R1<br>* q.d. PO, Placebo of DW1903 + DW1903-R1<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy rate on gastroscopy | The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration. The efficacy rate(%) = (number of effective cases)/(all cases) x 100 Effective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case. | Week 0, Week2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate on gastroscopy | Judging from the gastroscopic examination as normal (no erosion), the cure rate is obtained as follows. Cure rate(%) = (number of cures(no erosion))/(all cases) x 100 | Week 0, Week2 |