A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain

August 12, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain

A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

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

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:

  • 20≤ Age ≤ 70
  • Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

  • Neuropathic pain due to other causes
  • Another stronger pain other than neuropathic pain
  • Abnormality in blood pressure, weight
  • Positive reaction in HIV, HBV or HCV
  • A medical history of mental illness within 6 months
  • The grade of BDI(Beck Depression Inventory) exceeds 21 points
  • History of drug/alcohol abuse

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 600㎍ of DA-3030 Injection
600㎍ of DA-3030 is injected once a day, for 5 continuous days.
Drug: 600㎍ of DA-3030 Injection
Placebo Comparator: Placebo
Placebo(a salin drip) is injected once a day, for 5 continuous days.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test
Time Frame: 12 Weeks
12 Weeks
Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average pain score
Time Frame: 12 Weeks
Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)
12 Weeks
Most severe pain score
Time Frame: 12 weeks
Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)
12 weeks
overnight pain score
Time Frame: 12 weeks
Measuring how much the subject feels pain last night on a scale of one to ten (no pain - most severe pain)
12 weeks

Collaborators and Investigators

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

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Yoo Heon Ahn, M.D., Ph.D., Hanyang University
  • Principal Investigator: Bong Yeon Cha, M.D., Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea
  • Principal Investigator: Kyung Soo Ko, M.D, Ph.D., Inje University
  • Principal Investigator: Tae Sun Park, M.D., Ph.D., Chonbuk National University Hospital
  • Principal Investigator: Young Soo Park, M.D.,Ph.D., Hanyang University
  • Principal Investigator: Choon Hee Chung, M.D., Ph.D., Wonju Christian Hospital
  • Principal Investigator: In Joo Kim, M.D., Ph.D., Pusan 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

June 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3030_DN_I (Version 3.4)

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.

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