drugset / Trial / NCT01813799

Study of DA-9801 to Treat Diabetic Neuropathic Pain

NCT01813799 ↗

Phase 2 Completed 128 enrolled Dong-A ST Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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 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.

Timeline

Start
2011-11
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject DA-9801 Unknown 300 mg —
Subject DA-9801 Unknown 600 mg —
Subject DA-9801 Unknown 900 mg —

Indications