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Completed

NCT Number: NCT01820715

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

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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hanyang University Medical Center

Seoul, 133-791, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

600㎍ of DA-3030 Injection

Drug

Placebo

Drug

Primary outcomes

  1. 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

    Time frame: 12 Weeks

  2. Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event

    Time frame: 12 weeks

Secondary outcomes

  1. Average pain score

    Time frame: 12 Weeks

    Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)

  2. Most severe pain score

    Time frame: 12 weeks

    Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)

  3. overnight pain score

    Time frame: 12 weeks

    Measuring how much the subject feels pain last night on a scale of one to ten (no pain - most severe pain)

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
First posted
Mar 29, 2013
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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