- Male and female subjects aged 18 years or older
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to
diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6
months to 5 years (inclusive).
- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue
Scale, at randomization, subjects must have completed at least 5 daily pain
interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- Patient who are willing and capable to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Women of childbearing potential are willing to use contraception during study.
- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization
as compared to screening; and during the 1 week screening period, with more than one
- Subject has other kinds of neurological disorder, pain of other reason, or skin
condition that could confuse the assessment.
- Subject with any other serious or unstable condition which in the opinion of the
investigator might compromise participation in the study.