To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients

Study Overview
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Brief Summary
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Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis

Official Title
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A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients

Conditions
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Gastritis Acute, Gastritis Chronic

Intervention / Treatment
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* Drug: Test(DW1401)
* Drug: Reference(Stillen tab.)


Participation Criteria
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Eligibility Criteria
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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. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit) 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
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Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test(DW1401)<br>tid PO, DW1401+Placebo of Stillen tab. | Drug: Test(DW1401)<br>* DW1401+Placebo of Stillen tab.<br>|
| Active Comparator: Reference(Stillen tab.)<br>tid PO, Stillen tab.+Placebo of DW1401 | Drug: Reference(Stillen tab.)<br>* Stillen tab.+Placebo of DW1401<br>|

What is the study measuring?
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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. | 0, week 2 | 

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 | 0, week 2 |