To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1
Site Reference ID/Investigator# 62887
Anaheim, California, United States
Site Reference ID/Investigator# 62824
Walnut Creek, California, United States
Site Reference ID/Investigator# 63710
Milford, Connecticut, United States
Site Reference ID/Investigator# 62884
24-hour Average Pain Score
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
Time frame: 12 weeks
Neuropathic Pain Symptom Inventory
Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)
Time frame: 12 weeks
Patient Global Impression of Change
Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication
Time frame: 12 weeks
Brief Pain Inventory
Capture the subject's severity of pain and interference
Time frame: 12 weeks
Neuropathic Pain Impact on Quality of Life Questionnaire
Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life
Time frame: 12 weeks
EuroQuality of Life - 5 Dimension -5 Level
Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Time frame: 12 weeks
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Placebo capsules
Duloxetine capsules
DeLand, Florida, United States
Site Reference ID/Investigator# 62826
Orlando, Florida, United States
Site Reference ID/Investigator# 63703
Brockton, Massachusetts, United States
Site Reference ID/Investigator# 73913
Olive Branch, Mississippi, United States
Site Reference ID/Investigator# 62886
Dallas, Texas, United States