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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820715

Enrollment

Registered

2013-03-29

Start date

2010-06-30

Completion date

Unknown

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

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.

Interventions

DRUG600㎍ of DA-3030 Injection

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026