Study of DA-9801 to Treat Diabetic Neuropathic Pain

April 14, 2019 updated by: Dong-A ST Co., Ltd.

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.

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 Overview

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Jeonju, Korea, Republic of, 561-712
        • Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
EXPERIMENTAL: 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.
EXPERIMENTAL: 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.
EXPERIMENTAL: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Time Frame: 8 weeks
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-group difference in average 24-h pain intensity (Likert scale)
Time Frame: 8 weeks
The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.
8 weeks
Most severe mean pain intensity (Likert Scale)
Time Frame: 4, 8 weeks
Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning.
4, 8 weeks
Overnight pain intensity (Likert Scale)
Time Frame: 4, 8 weeks
Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.
4, 8 weeks
Patient's Global Impression of improvement (1 point ~ 7 point)
Time Frame: 4, 8 weeks
Subject evaluated the level of symptom improvement during the visits after IP administration.
4, 8 weeks
Clinical Global Impression of severity (1 point ~ 7 point)
Time Frame: 4, 8 weeks
Investigator evaluated the level of symptom severity when a subject visited the institution.
4, 8 weeks
Average daily dose of acetaminophen
Time Frame: everyday(-2 weeks~0), everyday(0~8 weeks)
Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every
everyday(-2 weeks~0), everyday(0~8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bongyeon Cha, M.D., The Catholic University of Korea
  • Principal Investigator: Hyeok Sang Gwon, M.D., Catholic University Yeouido St. Mary's Hopspital
  • Principal Investigator: Inkyung Jeong, M.D., Gangdong Kyunghee University Hospital
  • Principal Investigator: Ji Hyeon Lee, M.D., Daegu Catholic University Medical Center
  • Principal Investigator: Jeong Guk Kim, M.D., Kyungpook National University Hospital
  • Principal Investigator: In Ju Kim, M.D., Busan National University Hospital
  • Principal Investigator: Young Min Cho, M.D., Seoul National University Hospital
  • Principal Investigator: Chun Hee Jung, M.D., Yonsei University Wonju Christian Hospital
  • Principal Investigator: Jyeong Hyeon Park, M.D., Inje University
  • Principal Investigator: Mun Seok Nam, M.D., Inha University Hospital
  • Principal Investigator: Dong Hyeok Cho, M.D., Chonnam National University Hospital
  • Principal Investigator: Min Kyong Moon, M.D., SMG-SNU Boramae Medical Center
  • Principal Investigator: Chong Hwa Kim, M.D., Sejong Hospital
  • Principal Investigator: Kwan Pyo Ko, M.D., Jeju National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (ESTIMATE)

March 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 14, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathies

Clinical Trials on DA-9801 300mg

3
Subscribe