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

Phase 1

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Drug: 600㎍ of DA-3030 Injection; Drug: Placebo

• Registration Number: NCT01820715
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2013-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
600㎍ of DA-3030 Injection	600㎍ of DA-3030 Injection	600㎍ of DA-3030 is injected once a day, for 5 continuous days.
Placebo	Placebo	Placebo(a salin drip) is injected once a day, for 5 continuous days.

Primary Outcome Measures

Name	Time	Method
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	12 Weeks
Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of