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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001140-47 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-894 | Drug | 6 mg BID tablets, 8 weeks of treatment |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly mean of 24-hour average pain score | Change from Baseline to final |
| Measure | Description | Time Frame |
|---|---|---|
| Pain improvement from Baseline to the final evaluation | 8-week | |
| Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain | 8-week | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Duan, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 6614 | Spring Valley | California | 91978 | United States | ||
| Site Reference ID/Investigator# 6617 |
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| Drug |
BID tablets, 8 weeks of treatment |
|
| Global assessments of study drug and pain status |
| 8-week |
| Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) | 8-week |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Site Reference ID/Investigator# 6356 | Hollywood | Florida | 33021 | United States |
| Site Reference ID/Investigator# 6615 | Tampa | Florida | 33603 | United States |
| Site Reference ID/Investigator# 6358 | Wellington | Florida | 33414 | United States |
| Site Reference ID/Investigator# 6609 | St Louis | Missouri | 63141 | United States |
| Site Reference ID/Investigator# 7229 | New Hyde Park | New York | 11042 | United States |
| Site Reference ID/Investigator# 6618 | Charlotte | North Carolina | 28211 | United States |
| Site Reference ID/Investigator# 6607 | Oklahoma City | Oklahoma | 73103 | United States |
| Site Reference ID/Investigator# 6575 | Allentown | Pennsylvania | 18103 | United States |
| Site Reference ID/Investigator# 8179 | San Antonio | Texas | 78229-4801 | United States |
| Site Reference ID/Investigator# 6616 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 5552 | Hradec Králové | 500 03 | Czechia |
| Site Reference ID/Investigator# 5554 | Olomouc | 77900 | Czechia |
| Site Reference ID/Investigator# 5553 | Zlín | 760 01 | Czechia |
| Site Reference ID/Investigator# 9363 | Corbeil-Essonnes | 91106 | France |
| Site Reference ID/Investigator# 5557 | Limoges | 87042 | France |
| Site Reference ID/Investigator# 6238 | Nevers | 58033 | France |
| Site Reference ID/Investigator# 6564 | Bad Mergentheim | 97980 | Germany |
| Site Reference ID/Investigator# 11201 | Berlin | 10115 | Germany |
| Site Reference ID/Investigator# 6234 | Düsseldorf | 40225 | Germany |
| Site Reference ID/Investigator# 11202 | Mainz | D - 55116 | Germany |
| Site Reference ID/Investigator# 7714 | Munich | 80804 | Germany |
| Site Reference ID/Investigator# 5549 | L’Aquila | 67100 | Italy |
| Site Reference ID/Investigator# 5558 | Perugia | 06126 | Italy |
| Site Reference ID/Investigator# 6475 | Granada | 18014 | Spain |
| Site Reference ID/Investigator# 7911 | Sabadell, Barcelona | 8208 | Spain |
| Site Reference ID/Investigator# 5555 | Birmingham | B29 6JD | United Kingdom |
| Site Reference ID/Investigator# 7133 | Sheffield | S5 7AU | United Kingdom |
| ID | Term |
|---|---|
| C000593913 | 3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane |
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