NCT01813799

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-03-19
• Last updated: 2019-04-16

Locations

1 site across 1 country: South Korea