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The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV411 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Tolerability | ||
| Pharmacokinetic profile | ||
| Pharmacodynamic profile |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | ||
| Visual Analog Scale | ||
| Clinical Global Impression of Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Adelaide | Adelaide | Australia | ||||
| Peninsular Specialist Centre |
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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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| ID | Term |
|---|---|
| C038366 | ibudilast |
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| Use of analgesic or adjuvant medications for neuropathic pain |
| Correlation between plasma concentrations of AV411 and pain intensity assessments |
| Kipparing |
| Australia |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |