Completed
A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain
What is being tested
600㎍ of DA-3030 Injection
+ Placebo
Drug
Who is being recruted
Diabetes Mellitus+4
+ Endocrine System Diseases
+ Nervous System Diseases
From 20 to 70 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1
Interventional
Study Start: June 2010
Summary
Principal SponsorDong-A Pharmaceutical Co., Ltd.
Last updated: August 13, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2010
Actual date on which the first participant was enrolled.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.
Principal SponsorDong-A Pharmaceutical Co., Ltd.
Last updated: August 13, 2013
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
31 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
20 <= Age <= 70
Diagnosed with Type I or Type II diabetes
HbA1c <= 11%
Patients corresponding to average pain level of 4 points or mor for 24 hours evaluated with 11-point Likert scale
Show More Criteria
7 exclusion criteria prevent from participating
A medical history of mental illness within 6 months
Abnormality in blood pressure, weight
Another stronger pain other than neuropathic pain
History of drug/alcohol abuse
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
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental600㎍ of DA-3030 is injected once a day, for 5 continuous days.
Group II
PlaceboPlacebo(a salin drip) is injected once a day, for 5 continuous days.
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
Hanyang University Medical Center
Seoul, South KoreaOpen Hanyang University Medical Center in Google MapsCompletedOne Study Center