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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
193
ABT-639 Twice Daily for six weeks.
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Placebo twice daily for 6 weeks.
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Daily questions asked on a hand held diary
Time frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Patient's Global Impression of Change
Paper questionnaire
Time frame: Week 2, Week 4 and Week 6 (End of Study)
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Paper questionnaire
Time frame: At each visit up to Week 6 (end of Study)
Neuropathic Pain Symptom Inventory (NPSI)
Paper questionnaire
Time frame: Baseline, Week 2, Week 4 and Week 6 (end of Study)
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Site Reference ID/Investigator# 51807
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 51946
Anaheim, California, United States
Site Reference ID/Investigator# 51468
Long Beach, California, United States
Site Reference ID/Investigator# 52744
Walnut Creek, California, United States
Site Reference ID/Investigator# 51079
Clearwater, Florida, United States
Site Reference ID/Investigator# 51076
Hialeah, Florida, United States
Site Reference ID/Investigator# 51945
Hollywood, Florida, United States
Site Reference ID/Investigator# 51077
Ocala, Florida, United States
Site Reference ID/Investigator# 51078
Orlando, Florida, United States
Site Reference ID/Investigator# 51804
Brockton, Massachusetts, United States
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