Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetic Neuropathies Pain Efficacy of pregabalin Placebo controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Patient take pregabalin capsule twice a day arm 2: None

Interventions: intervention 1: Pregabalin intervention 2: Placebo matched with pregabalin
Intervention descriptions: intervention 1: 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be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.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. intervention 2: Subject will take placebo matched with pregabalin twice a day.

Protocol document: