A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain

Inclusion Criteria:

• Males or females 18-75 years of age
• Diabetes mellitus (type I or type II)
• No change in medications for reducing blood sugar within 4 weeks before screening
• Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
• Neuropathic pain must begin in the feet, with relatively symmetrical onset.
• Willing to perform self-monitoring of blood glucose
• Able to communicate intelligibly with the investigator and study coordinator
• Keeping all appointments for clinic visits, tests, and procedures

Exclusion Criteria:

• Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
• Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
• Prior renal transplant or current renal dialysis
• Pernicious anemia
• Untreated hypothyroidism
• Amputations due to diabetes mellitus (with the exception of toes)
• Any clinically significant abnormal electrocardiogram (ECG)
• Any history of cardiac arrhythmia
• History of myocardial infarction
• Active angina
• Uncontrolled hypertension (i.e., > 140/90 mm Hg)
• Known or at high risk of hepatitis B or C infection
• Known or at high risk of human immunodeficiency virus (HIV) infection
• Any anticipated need for surgery during the study
• Glycosylated hemoglobin (HbA1c) > 9%
• Known seizure disorder
• Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
• Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain.
• Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents
• History of substance abuse or dependence within the past year, excluding nicotine and caffeine
• Frequent and/or severe allergic reactions with multiple medications
• Participation in any clinical trial within 30 days before screening