Study of DA-9801 to Treat Diabetic Neuropathic Pain

A Multicenter, Placebo-controlled, Randomized, Double-blind, Phase II Clinical Trial With Diabetic Neuropathy Patients is Designed to Evaluate the Safety and Efficacy of the DA-9801 Tablet for Neuropathic Pain and to Decide Optimal Dose.

This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in the treatment of pain associated with diabetic neuropathy. Subjects will receive either 300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.

Inclusion Criteria:

• the age of 20 ~ 70
• Type I or Type II Diabetes
• HbA1c ≤11%
• Patients with diabetic neuropathic pain for at least 3 months
• Patients corresponding to average pain level of 4 points or more for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

• neuropathic pain due to other causes or another stronger pain other than neuropathic pain
• abnormal in blood pressure, weight, ALT/AST, Serum creatinine
• positive reaction in HIV, HBV, or HCV
• experience of suicide try or Mental Illness Medical History
• BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history