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The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | IMX-150 (0.3%) 0.5 g topically BID each foot |
|
| B | Experimental | IMX-150(0.6%) 0.5 g topically BID to each foot |
|
| C | Placebo Comparator | Placebo 0.5 g topically BID to each foot for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMX-150 | Drug | (0.3%) 0.5g topically BID to each foot for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores | Weekly average of "24-hour Average Pain" |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly average sleep disturbance | daily |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yeramian, MD | VP Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meriden Research | Brooksville | Florida | 34613 | United States | ||
| Health Awareness |
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| IMX-150 |
| Drug |
(0.6%) 0.5g topically BID to each foot for 4 weeks |
|
| Placebo | Drug | 0.5 g topically BID to each foot for 4 weeks |
|
| Jupiter |
| Florida |
| 33458 |
| United States |
| International Research Associates, LLC | Miami | Florida | 33156 | United States |
| Peninsula Research | Ormond Beach | Florida | 32174 | United States |
| Alpha Medical Research | Oviedo | Florida | 32765 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Hampton Roads Center for Clinical Research | Norfolk | Virginia | 23502 | United States |