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A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600㎍ of DA-3030 Injection | Experimental | 600㎍ of DA-3030 is injected once a day, for 5 continuous days. |
|
| Placebo | Placebo Comparator | Placebo(a salin drip) is injected once a day, for 5 continuous days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 600㎍ of DA-3030 Injection | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test | 12 Weeks | |
| Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average pain score | Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain) | 12 Weeks |
| Most severe pain score | Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoo Heon Ahn, M.D., Ph.D. | Hanyang University | Principal Investigator |
| Bong Yeon Cha, M.D., Ph.D. | Seoul St. Mary's Hospital, The Catholic University of Korea | Principal Investigator |
| Kyung Soo Ko, M.D, Ph.D. | Inje University | Principal Investigator |
| Tae Sun Park, M.D., Ph.D. | Chonbuk National University Hospital | Principal Investigator |
| Young Soo Park, M.D.,Ph.D. | Hanyang University Guri Hospital | Principal Investigator |
| Choon Hee Chung, M.D., Ph.D. | Wonju Christian Hospital | Principal Investigator |
| In Joo Kim, M.D., Ph.D. | Pusan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Medical Center | Seoul | 133-791 | South Korea |
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| 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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|
| 12 weeks |
| overnight pain score | Measuring how much the subject feels pain last night on a scale of one to ten (no pain - most severe pain) | 12 weeks |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |