Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet

Study Overview
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Brief Summary
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To Evaluate the Efficacy and Safety of CKD-495

Detailed Description
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A Phase 2, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients with Acute and Chronic Gastritis

Official Title
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A Phase 2, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis

Conditions
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Gastritis

Intervention / Treatment
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* Drug: CKD-495 75mg
* Drug: CKD-495 150mg
* Drug: Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg
* Drug: Rebamipide 100mg
* Drug: Placebo of the CKD-495 75mg
* Drug: Placebo of the CKD-495 150mg
* Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
* Drug: Placebo of the Rebamipide 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female subjects aged ≥ 19 Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date Patients who have more than 1 subjective symptom Exclusion Criteria: Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis Patients who have to take medicine that could cause gastritis

Ages Eligible for Study
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Minimum Age: 19 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: Experimental Group 1<br>Patients assigned to this group are treated with CKD-495 75mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 150mg, ,Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.) | Drug: CKD-495 75mg<br>* CKD-495 75mg Tab.<br>Drug: Placebo of the CKD-495 150mg<br>* Placebo of the CKD-495 150mg Tab.<br>Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg<br>* Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.<br>Drug: Placebo of the Rebamipide 100mg<br>* Placebo of the Rebamipide 100mg Tab<br>|
| Experimental: Experimental Group 2<br>Patients assigned to this group are treated with CKD-495 150mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.) | Drug: CKD-495 150mg<br>* CKD-495 150mg Tab.<br>Drug: Placebo of the CKD-495 75mg<br>* Placebo of the CKD-495 75mg Tab.<br>Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg<br>* Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.<br>Drug: Placebo of the Rebamipide 100mg<br>* Placebo of the Rebamipide 100mg Tab<br>|
| Placebo Comparator: Placebo Group<br>Patients assigned to this group are treated with 4 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.) | Drug: Placebo of the CKD-495 75mg<br>* Placebo of the CKD-495 75mg Tab.<br>Drug: Placebo of the CKD-495 150mg<br>* Placebo of the CKD-495 150mg Tab.<br>Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg<br>* Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.<br>Drug: Placebo of the Rebamipide 100mg<br>* Placebo of the Rebamipide 100mg Tab<br>|
| Active Comparator: Active comparator Group 1<br>Patients assigned to this group are treated with Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of the Rebamipide 100mg Tab.) | Drug: Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg<br>* Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.<br>Drug: Placebo of the CKD-495 75mg<br>* Placebo of the CKD-495 75mg Tab.<br>Drug: Placebo of the CKD-495 150mg<br>* Placebo of the CKD-495 150mg Tab.<br>Drug: Placebo of the Rebamipide 100mg<br>* Placebo of the Rebamipide 100mg Tab<br>|
| Active Comparator: Active comparator Group 2<br>Patients assigned to this group are treated with Rebamipide 100mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.) | Drug: Rebamipide 100mg<br>* Rebamipide 100mg Tab.<br>Drug: Placebo of the CKD-495 75mg<br>* Placebo of the CKD-495 75mg Tab.<br>Drug: Placebo of the CKD-495 150mg<br>* Placebo of the CKD-495 150mg Tab.<br>Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg<br>* Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate of gastric erosion | 50% decreased on erosive grade | 14days after drug administrations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate of gastric erosion | 0 erosion | 14days after drug administrations | 
| Improvement rate of symptoms | 50% decreased on the Subjective Symptoms total score | 14days after drug administrations | 
| Improvement rate of gastric edema | 50% decreased on the Edema grade | 14days after drug administrations | 
| Improvement rate of gastric erythema | 50% decreased on the Erythema grade | 14days after drug administrations | 
| Improvement rate of gastric hemorrhage | 50% decreased on the Hemorrhage grade | 14days after drug administrations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-495, Acute Gastritis, Chronic Gastritis, Cinnamic acid