Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

• Drug: placebo
  
  Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
• Drug: pregabalin
  
  Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
• Drug: pregabalin
  
  Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

• Placebo Comparator: Placebo
  
  Intervention: Drug: placebo
• Experimental: Pregabalin 300 mg/day
  
  Intervention: Drug: pregabalin
• Experimental: Pregabalin 600 mg/day
  
  Intervention: Drug: pregabalin

Inclusion Criteria:

• Visual Analogue Scale (VAS) of pain is higher than 40 mm.
• Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

• Malignancy within the past 2 years.
• Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain