Status:
COMPLETED
Study of DA-9801 to Treat Diabetic Neuropathic Pain
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01813799
Start Date
November 1 2011
End Date
July 1 2013
Last Update
April 16 2019
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, South Korea, 561-712