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This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-5204 | Experimental | DA-5204 administered two times daily for two weeks |
|
| Stillen tab. | Active Comparator | Stillen tab. administered three times daily for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-5204 | Drug |
| ||
| Stillen tab. |
| Measure | Description | Time Frame |
|---|---|---|
| A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy. | The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions] | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A percentage of completely cured subject after a treatment | The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy. | 2 weeks |
| A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Ho Lee, M.D., Ph.D. | Seoul National University Bundang Hospital of Korea | Principal Investigator |
| Myung Gyu Choi, M.D., Ph.D. | The Catholic University, Seoul St. Mary's Hospital of Korea | Principal Investigator |
| Sung Joon Lee, M.D., Ph.D. | Kangwon National University Hospital of Korea | Principal Investigator |
| Sung Kuk Kim, M.D., Ph.D. | Kyungbuk National University Hospital of Korea | Principal Investigator |
| Geun Am Song, M.D., Ph.D. | Pusan National Universtiy Hospital of Korea | Principal Investigator |
| Poong Lyeol Lee, M.D., Ph.D. | Samsung Medical Center of Korea | Principal Investigator |
| Hwoon Yong Jung, M.D., Ph.D. | Asan Medical Center of Korea | Principal Investigator |
| Dae Hwan Kang, M.D., Ph.D. | Pusan National University Yangsan Hospital of Korea | Principal Investigator |
| Yong Chan Lee, M.D., Ph.D. | Yonsei University, Severance Hospital of Korea |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Universtiy, Bundang Hospital, IRB | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28960033 | Derived | Choi YJ, Lee DH, Choi MG, Lee SJ, Kim SK, Song GA, Rhee PL, Jung HY, Kang DH, Lee YC, Lee SH, Choi SC, Shim KN, Seol SY, Moon JS, Shin YW, Kim HS, Lee ST, Cho JW, Choi EK, Lee OY, Jang JS. Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study. J Korean Med Sci. 2017 Nov;32(11):1807-1813. doi: 10.3346/jkms.2017.32.11.1807. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 19, 2016 | |
| Reset | Nov 4, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 19, 2016 | Nov 4, 2016 |
| ID | Term |
|---|---|
| C000711370 | DA-5204 |
| C116959 | DA 9601 |
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The definition of "moderate improvement" is the subjects showed reduction ratio of score changed from 50% to 75%. And, "singnificant improvement" means the subjects showed reduction ratio of score changed 75% or more. Reduction ratio of score is calculated as [1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)]. |
| 2 weeks |
| Principal Investigator |
| Si Hyung Lee, M.D., Ph.D. | Yeungnam University Hospital of Korea | Principal Investigator |
| Suck Chei Choi, M.D., Ph.D. | Wonkwang University Hospital of Korea | Principal Investigator |
| Gi Nam Sim, M.D., Ph.D. | Ewha Womans University Medical Center of Korea | Principal Investigator |
| Sang Young Seoul, M.D., Ph.D. | Inje University Busan Paik Hospital of Korea | Principal Investigator |
| Jeong Seop Moon, M.D., Ph.D. | Inje University Seoul Paik Hospital of Korea | Principal Investigator |
| Yong Woon Shin, M.D., Ph.D. | Inha University Hospital of Korea | Principal Investigator |
| Hyen Soo Kim, M.D., Ph.D. | Chonnam National Universtiy Hospital of Korea | Principal Investigator |
| Soo Teik Lee, M.D., Ph.D. | Chonbuk National Universtiy Hospital of Korea | Principal Investigator |
| Jin Woong Cho, M.D., Ph.D. | The Presbyterian medical center in Jeonju of Korea | Principal Investigator |
| Eun Kwang Choi, M.D., Ph.D. | Jeju National Universtiy Hospital of Korea | Principal Investigator |
| Soon Man Yoon, M.D., Ph.D. | Chungbuk National University Hospital of Korea | Principal Investigator |
| Oh Young Lee, M.D., Ph.D. | Hanyang Universtiy Hospital of Korea | Principal Investigator |
| Jin Seok Jang, M.D., Ph.D. | Dong-A University Hospital of Korea | Principal Investigator |