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

Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820715
• Other study ID #: DA3030_DN_I (Version 3.4)
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2013
• Last updated: August 12, 2013
• Start date: June 2010

Study information

• Verified date: August 2013
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Neuralgia

Intervention

Drug:
• 600? of DA-3030 Injection

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event		12 weeks	Yes
Secondary	Average pain score	Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)	12 Weeks	No
Secondary	Most severe pain score	Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)	12 weeks	No
Secondary	overnight pain score	Measuring how much the subject feels pain last night on a scale of one to ten (no pain - most severe pain)	12 weeks	No