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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Weekly mean of 24-hour average pain score
Time frame: Change from Baseline to final
Pain improvement from Baseline to the final evaluation
Time frame: 8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
Time frame: 8-week
Global assessments of study drug and pain status
Time frame: 8-week
Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)
Time frame: 8-week
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Site Reference ID/Investigator# 6614
Spring Valley, California, United States
Site Reference ID/Investigator# 6617
Walnut Creek, California, United States
Site Reference ID/Investigator# 6356
Hollywood, Florida, United States
Site Reference ID/Investigator# 6615
Tampa, Florida, United States
Site Reference ID/Investigator# 6358
Wellington, Florida, United States
Site Reference ID/Investigator# 6609
St Louis, Missouri, United States
Site Reference ID/Investigator# 7229
New Hyde Park, New York, United States
Site Reference ID/Investigator# 6618
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 6607
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 6575
Allentown, Pennsylvania, United States
...and 19 more locations