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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
ABT-894 1 mg capsule BID throughout treatment period
ABT-894 2 mg capsule BID throughout treatment period
ABT-894 4 mg capsule BID throughout treatment period
placebo capsule BID throughout the treatment period
Duloxetine 60 mg QD throughout treatment period
Site Reference ID/Investigator# 5207
Mesa, Arizona, United States
Site Reference ID/Investigator# 6053
Phoenix, Arizona, United States
Site Reference ID/Investigator# 5206
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 7387
North Little Rock, Arkansas, United States
Site Reference ID/Investigator# 6052
Anaheim, California, United States
Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP
Time frame: Change from baseline to final 24-hour average pain score
Proportions of treatment responders; subjects who complete treatment period with 30% improvement
Time frame: 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
Time frame: Weekly through treatment phase
Brief Pain Inventory (BPI) (short form) including Pain Severity
Time frame: At each visit from Baseline to Week 8 visit
Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C)
Time frame: At each visit from Baseline to Week 8 visit
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Site Reference ID/Investigator# 7064
Garden Grove, California, United States
Site Reference ID/Investigator# 8286
National City, California, United States
Site Reference ID/Investigator# 5276
Clearwater, Florida, United States
Site Reference ID/Investigator# 6781
Hialeah, Florida, United States
Site Reference ID/Investigator# 7514
Palm Beach Gardens, Florida, United States
...and 39 more locations