Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001139-71 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | ABT-894 1 mg BID |
|
| B | Experimental | ABT-894 2 mg BID |
|
| C | Experimental | ABT-894 4 mg BID |
|
| D | Placebo Comparator |
| |
| E | Active Comparator | Duloxetine 60 mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-894 | Drug | ABT-894 1 mg capsule BID throughout treatment period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP | Change from baseline to final 24-hour average pain score |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of treatment responders; subjects who complete treatment period with 30% improvement | From Baseline to final 24-hour average pain score | |
| Mean of 24-hour worst pain severity, average of night pain, and average of morning pain measured by the 11-point Likert scale and from subject's daily diary |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wolfram Nothaft, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 5207 | Mesa | Arizona | 85210 | United States | ||
| Site Reference ID/Investigator# 6053 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ABT-894 |
| Drug |
ABT-894 2 mg capsule BID throughout treatment period |
|
| ABT-894 | Drug | ABT-894 4 mg capsule BID throughout treatment period |
|
| placebo | Drug | placebo capsule BID throughout the treatment period |
|
| Duloxetine | Drug | Duloxetine 60 mg QD throughout treatment period |
|
| Weekly through treatment phase |
| Brief Pain Inventory (BPI) (short form) including Pain Severity | At each visit from Baseline to Week 8 visit |
| Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C) | At each visit from Baseline to Week 8 visit |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Site Reference ID/Investigator# 5206 | Little Rock | Arkansas | 72205 | United States |
| Site Reference ID/Investigator# 7387 | North Little Rock | Arkansas | 72114 | United States |
| Site Reference ID/Investigator# 6052 | Anaheim | California | 92801 | United States |
| Site Reference ID/Investigator# 7064 | Garden Grove | California | 92845 | United States |
| Site Reference ID/Investigator# 8286 | National City | California | 91950 | United States |
| Site Reference ID/Investigator# 5276 | Clearwater | Florida | 33765 | United States |
| Site Reference ID/Investigator# 6781 | Hialeah | Florida | 33012 | United States |
| Site Reference ID/Investigator# 7514 | Palm Beach Gardens | Florida | 33418 | United States |
| Site Reference ID/Investigator# 8113 | Tampa | Florida | 33603 | United States |
| Site Reference ID/Investigator# 6047 | Pasadena | Maryland | 21122 | United States |
| Site Reference ID/Investigator# 5277 | Brockton | Massachusetts | 02301 | United States |
| Site Reference ID/Investigator# 6043 | St Louis | Missouri | 63117 | United States |
| Site Reference ID/Investigator# 6044 | St Louis | Missouri | 63141 | United States |
| Site Reference ID/Investigator# 7906 | Omaha | Nebraska | 68131 | United States |
| Site Reference ID/Investigator# 6045 | New York | New York | 10003 | United States |
| Site Reference ID/Investigator# 5946 | New York | New York | 10022 | United States |
| Site Reference ID/Investigator# 5216 | New York | New York | 10065 | United States |
| Site Reference ID/Investigator# 7483 | New York | New York | 10128 | United States |
| Site Reference ID/Investigator# 5947 | Cincinnati | Ohio | 45245 | United States |
| Site Reference ID/Investigator# 6869 | Cuyahoga Falls | Ohio | 44223 | United States |
| Site Reference ID/Investigator# 5217 | Portland | Oregon | 97239 | United States |
| Site Reference ID/Investigator# 7699 | Houston | Texas | 77074 | United States |
| Site Reference ID/Investigator# 5836 | San Antonio | Texas | 78218 | United States |
| Site Reference ID/Investigator# 5899 | San Antonio | Texas | 78229-4801 | United States |
| Site Reference ID/Investigator# 5950 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 7187 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 6054 | Seattle | Washington | 98104 | United States |
| Site Reference ID/Investigator# 8508 | Kingston | K7L 1G1 | Canada |
| Site Reference ID/Investigator# 8436 | Laval | H7T 2P5 | Canada |
| Site Reference ID/Investigator# 8481 | Winnipeg | R2V 4W3 | Canada |
| Site Reference ID/Investigator# 5258 | Corbeil-Essonnes | 91106 | France |
| Site Reference ID/Investigator# 7696 | Nanterre | 92104 | France |
| Site Reference ID/Investigator# 5260 | Narbonne | 11108 | France |
| Site Reference ID/Investigator# 5171 | Nevers | 58033 | France |
| Site Reference ID/Investigator# 7115 | Nîmes | 30029 | France |
| Site Reference ID/Investigator# 6763 | Berlin | 10115 | Germany |
| Site Reference ID/Investigator# 7117 | Essen | 45138 | Germany |
| Site Reference ID/Investigator# 5034 | Frankfurt | 60596 | Germany |
| Site Reference ID/Investigator# 6760 | Heidelberg | 69120 | Germany |
| Site Reference ID/Investigator# 6732 | Mainz | D - 55116 | Germany |
| Site Reference ID/Investigator# 5018 | Milan | 20132 | Italy |
| Site Reference ID/Investigator# 5006 | Rome | 00133 | Italy |
| Site Reference ID/Investigator# 8427 | Guadalajara | 44656 | Mexico |
| Site Reference ID/Investigator# 8497 | Mexico City | C.P. 11650 | Mexico |
| Site Reference ID/Investigator# 8125 | Monterrey, N.L. | C.P. 64460 | Mexico |
| Site Reference ID/Investigator# 8120 | Ponce | 00717-2075 | Puerto Rico |
| Site Reference ID/Investigator# 8121 | San Juan | 00907 | Puerto Rico |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000593913 | 3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided