Status:
COMPLETED
A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01820715
Start Date
June 1 2010
Last Update
August 13 2013
Active Locations (1)
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1
Hanyang University Medical Center
Seoul, South Korea, 133-791