A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain

A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain

A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.

Inclusion Criteria:

• 20≤ Age ≤ 70
• Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

• Neuropathic pain due to other causes
• Another stronger pain other than neuropathic pain
• Abnormality in blood pressure, weight
• Positive reaction in HIV, HBV or HCV
• A medical history of mental illness within 6 months
• The grade of BDI(Beck Depression Inventory) exceeds 21 points
• History of drug/alcohol abuse