Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.

• Drug: Pregabalin

  Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.

  At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.

• Drug: Placebo matched with pregabalin
  Subject will take placebo matched with pregabalin twice a day.

• Experimental: 300 mg/day pregabalin (Lyrica)
  Patient take pregabalin capsule twice a day
  Intervention: Drug: Pregabalin
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo matched with pregabalin

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 pain score <3 in pain scores.
• 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.