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To Evaluate the Efficacy and Safety of CKD-495
A phase 3, 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 | Experimental | Patients assigned to this group are treated with one CKD-495 75mg Tab.,and one Placebo Tab.(Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab) |
|
| Active comparator Group | Active Comparator | Patients assigned to this group are treated with one Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and one Placebo Tab.(Placebo of the CKD-495 75mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-495 75mg | Drug | CKD-495 75mg Tab. |
| |
| Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of gastric erosion | 50% change 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% change on the Subjective Symptoms total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oh Young Lee, MD, Ph.D. | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | Donggu | South Korea | |||
| Kyoungpook National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38065906 | Derived | Seo SY, Lee ST, Kim SK, Chun HJ, Song GA, Lee DH, Kim JJ, Kim JI, Lee YC, Kim TN, Jee SR, Park SY, Kim JG, Park JJ, Kim SG, Park JM, Park JH, Park SJ, Lee OY. Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial. Medicine (Baltimore). 2023 Dec 8;102(49):e35926. doi: 10.1097/MD.0000000000035926. |
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| Drug |
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab. |
|
| Placebo of the CKD-495 75mg | Drug | Placebo of the CKD-495 75mg 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. |
|
| 14days after drug administrations |
| Improvement rate of gastric edema | 50% change on the Edema grade | 14days after drug administrations |
| Improvement rate of gastric erythema | 50% change on the Erythema grade | 14days after drug administrations |
| Improvement rate of gastric hemorrhage | 50% change on the Hemorrhage grade | 14days after drug administrations |
| Daegu |
| Gyeongsangbuk-do |
| South Korea |
| Busan National University Hospital | Busan | Seo-gu | South Korea |
| Inje University Busan Paik Hospital | Busan | South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Chung Ang University Hospital | Seoul | South Korea |
| Hanyang University Medical Center | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | South Korea |
| Yeouido ST. Mary's 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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