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This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in the treatment of pain associated with diabetic neuropathy. Subjects will receive either 300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-9801 300mg | Experimental |
| |
| DA-9801 600mg | Experimental |
| |
| DA-9801 900mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-9801 300mg | Drug | 300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in average 24-h pain intensity (Likert scale) between before and after IP administration | Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-group difference in average 24-h pain intensity (Likert scale) | The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups. | 8 weeks |
| Most severe mean pain intensity (Likert Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bongyeon Cha, M.D. | The Catholic University of Korea | Principal Investigator |
| Hyeok Sang Gwon, M.D. | Catholic University Yeouido St. Mary's Hopspital | Principal Investigator |
| Inkyung Jeong, M.D. | Gangdong Kyunghee University Hospital | Principal Investigator |
| Ji Hyeon Lee, M.D. | Daegu Catholic University Medical Center | Principal Investigator |
| Jeong Guk Kim, M.D. | Kyungpook National University Hospital | Principal Investigator |
| In Ju Kim, M.D. | Busan National University Hospital | Principal Investigator |
| Young Min Cho, M.D. | Seoul National University Hospital | Principal Investigator |
| Chun Hee Jung, M.D. | Yonsei University Wonju Christian Hospital | Principal Investigator |
| Jyeong Hyeon Park, M.D. | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2019 | |
| Reset | Jul 23, 2019 | |
| Release | May 12, 2020 | |
| Reset | May 21, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2019 | Jul 23, 2019 | |||
| May 12, 2020 |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| C562027 | DA-9801 |
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| DA-9801 600mg | Drug | 600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day. |
|
| DA-9801 900mg | Drug | 900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day. |
|
| Placebo | Drug | Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day. |
|
Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning. |
| 4, 8 weeks |
| Overnight pain intensity (Likert Scale) | Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning. | 4, 8 weeks |
| Patient's Global Impression of improvement (1 point ~ 7 point) | Subject evaluated the level of symptom improvement during the visits after IP administration. | 4, 8 weeks |
| Clinical Global Impression of severity (1 point ~ 7 point) | Investigator evaluated the level of symptom severity when a subject visited the institution. | 4, 8 weeks |
| Average daily dose of acetaminophen | Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every | everyday(-2 weeks~0), everyday(0~8 weeks) |
| Mun Seok Nam, M.D. | Inha University Hospital | Principal Investigator |
| Dong Hyeok Cho, M.D. | Chonnam National University Hospital | Principal Investigator |
| Min Kyong Moon, M.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Chong Hwa Kim, M.D. | Sejong General Hospital | Principal Investigator |
| Kwan Pyo Ko, M.D. | Jeju National University Hospital | Principal Investigator |
| May 21, 2020 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |