Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Criteria
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