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This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 3 mg |
|
| 2 | Experimental | 20 mg |
|
| 3 | Experimental | 60 mg |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN 203818 | Drug | 3 mg Capsule twice daily for 4 weeks |
| |
| AGN 203818 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Daily Pain Score | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sleep interference score | Week 4 | |
| Beck depression inventory | Week 4 | |
| Quality of Life questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tacoma | Washington | United States |
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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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| Drug |
20 mg Capsule twice daily for 4 weeks |
|
| AGN 203818 | Drug | 60 mg Capsule twice daily for 4 weeks |
|
| placebo capsule | Drug | Capsule twice daily for 4 weeks |
|
| Week 4 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |