Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic 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.
Inclusion Criteria:

 -  diagnosis of diabetic neuropathy

 -  must have some pain daily in the lower limbs due to diabetic polyneuropathy for at
 least 3 months prior to enrollment

 -  must be willing to comply with study directions, write information in a diary (such as
 pain medications taken), read and comprehend written instructions, complete
 questionnaires, and have the ability to apply the cream as directed

 Exclusion Criteria:

 -  uncontrolled pain that has persisted for > 12 months.