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To Evaluate the Efficacy and Safety of CKD-495
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental | 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 | Experimental | 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 Comparator | 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 | Active Comparator | 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.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-495 75mg | Drug | CKD-495 75mg Tab. |
| |
| CKD-495 150mg |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of gastric erosion | 50% decreased on erosive grade | 14days after drug administrations |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | Donggu, Jebongro | 501-757 | South Korea | ||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40255536 | Derived | Park SH, Lee OY, Lee YC, Park KS, Park JJ, Park MI, Song GA, Lee DH, Jung H, Kim SK, Kim TN, Choi SC, Jee SR, Rew JS, Lee ST, Choi EK, Baik GH, Park SJ. 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. Can J Gastroenterol Hepatol. 2025 Apr 10;2025:2702089. doi: 10.1155/cjgh/2702089. eCollection 2025. |
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|
| Active comparator Group 2 | Active Comparator | 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 |
CKD-495 150mg Tab. |
|
| Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg | Drug | Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab. |
|
| Rebamipide 100mg | Drug | Rebamipide 100mg Tab. |
|
| Placebo of the CKD-495 75mg | Drug | Placebo of the CKD-495 75mg Tab. |
|
| Placebo of the CKD-495 150mg | Drug | Placebo of the CKD-495 150mg Tab. |
|
| Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg | Drug | Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab. |
|
| Placebo of the Rebamipide 100mg | Drug | Placebo of the Rebamipide 100mg Tab |
|
| 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 |
| Daegu |
| Gyeongsangbuk-do |
| South Korea |
| Kyungpook National University Hospital | Daegu | Gyeongsangbuk-do | South Korea |
| Kosin University Gospel Hospital | Busan | Seo-gu | 602-702 | South Korea |
| Busan National University Hospital | Busan | South Korea |
| Inje University Busan Paik Hospital | Busan | South Korea |
| Hallym University Chuncheon Seonsim Hospital | Chuncheon | South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Wonkwang University Hospital | Iksan | South Korea |
| Jeju National University Hospital | Jeju City | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Hanyang University Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
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