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This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in treatment of the patients with functional dyspepsia. The study is conducted with following methods: multi-centers, double blind, randomization, parallel. The subjects will receive Motilitone® or/and Pantoline®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motilione® | Experimental | 30 mg is administered with a tablet of placebo (Pantoline®) |
|
| Pantoline® | Active Comparator | 40mg is administered with a tablet of Motilitone® |
|
| Motilitone® and Pantoline® | Active Comparator | Both drugs are administered at once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motilitone ® | Drug |
| ||
| Pantoline® |
| Measure | Description | Time Frame |
|---|---|---|
| Subject global assessment by using 5-Likert scale and Binary outcome methods | 5-Likert scale: 0: worse
Binary outcome: yes/no | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dyspepsia(indigestion) symptoms occurred (Counted daily) | 6 weeks | |
| Assessment of NDI-K Quality of Life | 6 weeks | |
| Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung Kyu Choi, M.D., Ph.D. | The Catholic University of Korea | Principal Investigator |
| Kyu Chan Huh, M.D., Ph.D. | Konyang University Hospital | Principal Investigator |
| Sung Kook Kim, M.D., Ph.D. | Kyungpook National University Hospital | Principal Investigator |
| Kyung Sik Park, M.D., Ph.D. | Keimyung University Dongsan Medical Center | Principal Investigator |
| Joong Gu Gweon, M.D.,Ph.D. | Daegu Catholic University Medical Center | Principal Investigator |
| Geun Am Song, M.D., Ph.D. | Busan National University Hospital | Principal Investigator |
| Soo Jin Hong, M.D., Ph.D. | Soonchunhyang University Hospital | Principal Investigator |
| Na Young Kim, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Jung Il Son, M.D., Ph.D. | Kangbuk Samsung Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Medical Center | Suwon | South Korea |
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|
| Motilitone® and Pantoline® | Drug |
|
| 6 weeks |
| Poong Yul Lee, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Joon Sung Lee, M.D., Ph.D. | Soonchunhyang University Hospital | Principal Investigator |
| Hoon Yong Jung, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Hyo Jin Park, M.D., Ph.D. | Gangnam Severance Hospital | Principal Investigator |
| Yong Chan Lee, M.D., Ph.D. | Severance Hospital | Principal Investigator |
| Suk Chae Choi, M.D., Ph.D. | Wonkwang Medical Center | Principal Investigator |
| Hye Kyung Jung, M.D., Ph.D. | Iwha Womans Unversity Mokdong Hospital | Principal Investigator |
| Sam Ryong Ji, M.D., Ph.D. | Inje University | Principal Investigator |
| Jong Sun Ryu, M.D., Ph.D. | Chonnam National University Hospital | Principal Investigator |
| Oh Young Lee, M.D., Ph.D. | Hanyang University | Principal Investigator |