Study of DA-9801 to Treat Diabetic Neuropathic Pain

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

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.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Bongyeon Cha, M.D. · The Catholic University of Korea

• Hyeok Sang Gwon, M.D. · Catholic University Yeouido St. Mary's Hopspital

• Inkyung Jeong, M.D. · Gangdong Kyunghee University Hospital

• Ji Hyeon Lee, M.D. · Daegu Catholic University Medical Center

• Jeong Guk Kim, M.D. · Kyungpook National University Hospital

• In Ju Kim, M.D. · Busan National University Hospital

• Young Min Cho, M.D. · Seoul National University Hospital

• Chun Hee Jung, M.D. · Yonsei University Wonju Christian Hospital

• Jyeong Hyeon Park, M.D. · Inje University

• Mun Seok Nam, M.D. · Inha University Hospital

• Dong Hyeok Cho, M.D. · Chonnam National University Hospital

• Min Kyong Moon, M.D. · SMG-SNU Boramae Medical Center

• Chong Hwa Kim, M.D. · Sejong General Hospital

• Kwan Pyo Ko, M.D. · Jeju National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• South Korea

Study Locations