Study of DA-9801 to Treat Diabetic Neuropathic Pain

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathies

Treatments: Drug: DA-9801 300mg; Drug: DA-9801 900mg; Drug: DA-9801 600mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813799

DA9801_DN_II

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

DA-9801 300mg

Experimental group

Treatment:

Drug: DA-9801 300mg

DA-9801 600mg

Experimental group

Treatment:

Drug: DA-9801 600mg

DA-9801 900mg

Experimental group

Treatment:

Drug: DA-9801 900mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo