A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034

Study Overview
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Brief Summary
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This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.

Official Title
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A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034 Compared With Rebamipide in Patients With Acute or Chronic Gastritis

Conditions
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Acute Gastritis, Chronic Gastritis

Intervention / Treatment
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* Drug: DA-6034
* Drug: Rebamipide 300mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with acute gastritis or chronic gastritis 1 or more erosions found in the gastroscope examination Age should be: 20≤age≤75 Exclusion Criteria: A patient with peptic ulcer and a gastroesophageal reflux disease. Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation Had a surgery regarding gastroesophageal A patient with Zollinger-Ellison syndrome Had a medical history of a malignant tumor A patient who is currently taking anti-thrombotic drugs

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-6034 45mg<br>two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day. | Drug: DA-6034<br> <br> |
| Experimental: DA-6034 90mg<br>two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day. | Drug: DA-6034<br> <br> |
| Active Comparator: Rebamipide 300mg<br>two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day. | Drug: Rebamipide 300mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal). | The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4->1, 3->1, slight improvement: 4->3, 3->2 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of erosions diagnosed by the gastroscope |  | 2 weeks | 
| The severity of the digestive symptoms (Scale of 1 to 5) | the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone | 2 weeks |