Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Study Overview
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Brief Summary
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The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Detailed Description
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This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Official Title
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A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Conditions
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Acute Gastritis, Chronic Gastritis

Intervention / Treatment
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* Drug: DWP14012 X mg
* Drug: DWP14012 X mg placebo
* Drug: DWP14012 Y mg
* Drug: DWP14012 Y mg placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 19 and 75 years old based on the date of written agreement Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy Those who had experienced one or more subjective symptoms of gastritis Exclusion Criteria: Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP14012 X mg QD<br>Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo Evening: 1 tablet of DWP14012 Y mg placebo | Drug: DWP14012 X mg<br>* DWP14012 X mg, tablet, orally, once daily for 2 weeks<br>Drug: DWP14012 Y mg placebo<br>* DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks<br>|
| Experimental: DWP14012 Y mg BID<br>Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg Evening: 1 tablet of DWP14012 Y mg | Drug: DWP14012 X mg placebo<br>* DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks<br>Drug: DWP14012 Y mg<br>* DWP14012 Y mg, tablet, orally, twice daily for 2 weeks<br>|
| Placebo Comparator: placebo<br>Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo Evening: 1 tablet of DWP14012 Y mg placebo | Drug: DWP14012 X mg placebo<br>* DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks<br>Drug: DWP14012 Y mg placebo<br>* DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate of gastric mucosal erosion | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100 | at 2 weeks after the IP administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of gastric mucosal erosion | Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100 | at 2 weeks after the IP administration | 
| Cure rate of gastric mucosal edema | Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100 | at 2 weeks after the IP administration | 
| Improvement rate of gastric mucosal erythema | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100 | at 2 weeks after the IP administration | 
| Improvement rate of gastric mucosal bleeding | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100 | at 2 weeks after the IP administration | 
| Improvement rate of subjective symptoms | Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100 | at 2 weeks after the IP administration |