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

Phase 2

Completed

• Conditions: Gastritis
• Interventions: 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 150mg; Drug: Placebo of the CKD-495 75mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg

• Registration Number: NCT03437785
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

To Evaluate the Efficacy and Safety of CKD-495

Detailed Description

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

Study Timeline

• Study Start: 2018-01-16
• Status Verified: 2018-02
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-19
• Primary Completion: 2018-10-12
• Study Completion: 2018-10-12
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Male or Female subjects aged ≥ 19
2. 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
3. Patients who have more than 1 subjective symptom

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Exclusion Criteria

1. Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine
2. 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
3. Patients who have to take medicine that could cause gastritis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group 1	CKD-495 75mg	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.)
Experimental Group 1	Placebo of the CKD-495 150mg	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.)
Experimental Group 1	Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg	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.)
Experimental Group 1	Placebo of the Rebamipide 100mg	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.)
Experimental Group 2	CKD-495 150mg	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.)
Experimental Group 2	Placebo of the CKD-495 75mg	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.)
Experimental Group 2	Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg	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.)
Experimental Group 2	Placebo of the Rebamipide 100mg	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.)
Placebo Group	Placebo of the CKD-495 75mg	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.)
Placebo Group	Placebo of the CKD-495 150mg	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.)
Placebo Group	Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg	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.)
Placebo Group	Placebo of the Rebamipide 100mg	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.)
Active comparator Group 1	Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg	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.)
Active comparator Group 1	Placebo of the CKD-495 75mg	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.)
Active comparator Group 1	Placebo of the CKD-495 150mg	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.)
Active comparator Group 1	Placebo of the Rebamipide 100mg	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.)
Active comparator Group 2	Placebo of the CKD-495 75mg	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.)
Active comparator Group 2	Placebo of the CKD-495 150mg	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.)
Active comparator Group 2	Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg	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.)
Active comparator Group 2	Rebamipide 100mg	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.)

Primary Outcome Measures

Name	Time	Method
Improvement rate of gastric erosion	14days after drug administrations	50% decreased on erosive grade

Secondary Outcome Measures

Name	Time	Method
cure rate of gastric erosion	14days after drug administrations	0 erosion
Improvement rate of symptoms	14days after drug administrations	50% decreased on the Subjective Symptoms total score
Improvement rate of gastric edema	14days after drug administrations	50% decreased on the Edema grade
Improvement rate of gastric erythema	14days after drug administrations	50% decreased on the Erythema grade
Improvement rate of gastric hemorrhage	14days after drug administrations	50% decreased on the Hemorrhage grade

Trial Locations

Locations (16)

Chonnam National University Hospital; 🇰🇷 Gwangju, Donggu, Jebongro, Korea, Republic of

Hallym University Chuncheon Seonsim Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Busan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of

Wonkwang University Hospital; 🇰🇷 Iksan, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of