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This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-6034 45mg | Experimental | two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day. |
|
| DA-6034 90mg | Experimental | two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day. |
|
| Rebamipide 300mg | Active Comparator | two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-6034 | Drug |
| ||
| Rebamipide 300mg |
| Measure | Description | Time Frame |
|---|---|---|
| The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal). | The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4->1, 3->1, slight improvement: 4->3, 3->2 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of erosions diagnosed by the gastroscope | 2 weeks | |
| The severity of the digestive symptoms (Scale of 1 to 5) | the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Chae Jung, M.D., Ph.D. | Contact | 82-2-2072-0694 | snuhirb@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Chae Jung, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Soo Heon Park, M.D., Ph.D. | Catholic University Yeouido St. Mary's Hopspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| C121889 | recoflavone |
| C052785 | rebamipide |
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|
| 2 weeks |
| Seong Woo Jeon, M.D., Ph.D. |
| Kyungpook National University Hospital |
| Principal Investigator |
| Sang Woo Lee, M.D.,Ph.D. | Korea University Ansan Hospital | Principal Investigator |
| Dong Ho Lee, M.D.,Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Kook Lae Lee, M.D., Ph.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Ju Yung Cho, M.D., Ph.D. | Soonchunhyang University Hospital | Principal Investigator |
| Ki Myeong Lee, M.D., Ph.D. | Ajou University School of Medicine | Principal Investigator |
| Yongchan Lee, M.D., Ph.D. | Severance Hospital, Yonsei University | Principal Investigator |
| Sang Yong Seol, M.D., Ph.D. | Inje University | Principal Investigator |
| Jeong Seop Moon, M.D., Ph.D. | Inje University | Principal Investigator |
| Jong Sun Rew, M.D., Ph.D. | Chonnam National University Hospital | Principal Investigator |
| Soo Taek Lee, M.D., Ph.D. | Chonbuk National University Hospital | Principal Investigator |
| Chan Kook Park, M.D., Ph.D. | Chosun University Hospital | Principal Investigator |
| Jae Gyu Kim, M.D., Ph.D. | Chung-Ang University Hospital | Principal Investigator |
| Sei Jin Youn, M.D., Ph.D. | Chungbuk National University Hospital | Principal Investigator |
| Hak Yang Kim, M.D., Ph.D. | Hallym University Medical Center | Principal Investigator |
| Byung Chul Yoon, M.D., Ph.D. | Hanyang University | Principal Investigator |
| Suck Chei Choi, M.D., Ph.D. | Wonkwang University Hospital | Principal Investigator |
| Ki Nam Shim, M.D., Ph.D. | Ewha Womans University Mokdong Hospital | Principal Investigator |