Diabetic Neuropathy Clinical Trial
Official title:
Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy
The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.
Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and
numbness, which affects the patients sleep, functioning and well-being. The pain is often
accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting.
The pain is usually symmetrical and occurs in the upper and lower extremities following a
"glove and stocking" distribution.
To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored
individually according to subject complaints and may be selected from categories including
Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic
antidepressants and anticonvulsants).
The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the
treatment of diabetic neuropathy as compared to placebo.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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