Trial | NCT01813799  Report issue

Title

Study of DA-9801 to Treat Diabetic Neuropathic Pain
A Multicenter, Placebo-controlled, Randomized, Double-blind, Phase II Clinical Trial With Diabetic Neuropathy Patients is Designed to Evaluate the Safety and Efficacy of the DA-9801 Tablet for Neuropathic Pain and to Decide Optimal Dose.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    da-9801 ...

  • Study Participants

    128
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.
Study Started
Nov 30
2011
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
Apr 16
2019

Drug DA-9801 300mg

300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Drug DA-9801 600mg

600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Drug DA-9801 900mg

900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Drug Placebo

Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

DA-9801 300mg Experimental

DA-9801 600mg Experimental

DA-9801 900mg Experimental

Placebo Placebo Comparator

Criteria 

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
No Results Posted