The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
155
Meriden Research
Brooksville, Florida, United States
Health Awareness
Jupiter, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Peninsula Research
Ormond Beach, Florida, United States
Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores
Time frame: Weekly average of "24-hour Average Pain"
Change in weekly average sleep disturbance
Time frame: daily
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Alpha Medical Research
Oviedo, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States