A Study to Evaluate the Efficacy and Safety of DA-5204

Study Overview
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Brief Summary
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This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.

Official Title
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A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5204 and to Demonstrate the Non-inferiority of DA-5204 Compared With Stillen Tab. in Patients With Acute or Chronic Gastritis

Conditions
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Acute Gastritis, Chronic Gastritis

Intervention / Treatment
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* Drug: DA-5204
* Drug: Stillen tab.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is over 20 years old, under 75 years old, men or women Patients diagnosed with acute or chronic gastritis by gastroscopy Patients with one or more erosions found by gastroscopy Signed the informed consent forms Exclusion Criteria: Patients who is impossible to receive gastroscopy Patients with peptic ulcer and gastroesophageal reflux disease Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks Patients with surgery related to gastroesophageal Patients with Zollinger-Ellison syndrome Patients with any kind of malignant tumor Patients administered with anti-thrombotic drugs Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease Patients with neuropsychiatric disorder, alcoholism, or drug abuse Patients taking other investigational drugs or participating in other clinical studies in 4 weeks. Women either pregnant or breast feeding

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: DA-5204<br>DA-5204 administered two times daily for two weeks | Drug: DA-5204<br> <br> |
| Active Comparator: Stillen tab.<br>Stillen tab. administered three times daily for two weeks | Drug: Stillen tab.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy. | The definition of moderate improvement is the subjects showed score changed from 4 to 1 or from 2 to 1. And, significant improvement means the subject showed score changed from 4 to 1 or from 3 to 1. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions] | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A percentage of completely cured subject after a treatment | The definition of completely cured is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy. | 2 weeks | 
| A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale. | The definition of moderate improvement is the subjects showed reduction ratio of score changed from 50% to 75%. And, singnificant improvement means the subjects showed reduction ratio of score changed 75% or more. Reduction ratio of score is calculated as [1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)]. | 2 weeks |