Completed

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.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

DA-9801 300mg

+ DA-9801 600mg

+ DA-9801 900mg

Drug
Who is being recruted

Diabetes Mellitus+4

+ Endocrine System Diseases

+ Nervous System Diseases

From 20 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2011
See protocol details

Summary

Principal SponsorDong-A ST Co., Ltd.
Last updated: April 16, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01813799
Principal SponsorDong-A ST Co., Ltd.
Last updated: April 16, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesNervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesDiabetes ComplicationsDiabetic Neuropathies

Criteria

5 inclusion criteria required to participate
HbA1c <= 11%
Patients corresponding to average pain level of 4 points or more for 24 hours evaluated with 11-point Likert scale
Patients with diabetic neuropathic pain for at least 3 months
Type I or Type II Diabetes
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5 exclusion criteria prevent from participating
BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history
abnormal in blood pressure, weight, ALT/AST, Serum creatinine
experience of suicide try or Mental Illness Medical History
neuropathic pain due to other causes or another stronger pain other than neuropathic pain
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Chonbuk National University Hospital

Jeonju, South KoreaOpen Chonbuk National University Hospital in Google Maps
CompletedOne Study Center