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

NCT01820715 | Completed Phase 1

• 1 other identifier: DA3030_DN_I (Version 3.4)
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Average pain score

  12 Weeks

• Most severe pain score

  12 weeks

• overnight pain score

  12 weeks

Study Arms (2)

600㎍ of DA-3030 Injection

EXPERIMENTAL

600㎍ of DA-3030 is injected once a day, for 5 continuous days.

Drug: 600㎍ of DA-3030 Injection

Placebo

PLACEBO COMPARATOR

Placebo(a salin drip) is injected once a day, for 5 continuous days.

Drug: Placebo

Interventions

600㎍ of DA-3030 Injection DRUG

600㎍ of DA-3030 Injection

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hanyang University Medical Center

Seoul, 133-791, South Korea

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Yoo Heon Ahn, M.D., Ph.D.

  Hanyang University

  PRINCIPAL INVESTIGATOR

• Bong Yeon Cha, M.D., Ph.D.

  Seoul St. Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Kyung Soo Ko, M.D, Ph.D.

  Inje University

  PRINCIPAL INVESTIGATOR

• Tae Sun Park, M.D., Ph.D.

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Young Soo Park, M.D.,Ph.D.

  Hanyang University Guri Hospital

  PRINCIPAL INVESTIGATOR

• Choon Hee Chung, M.D., Ph.D.

  Wonju Christian Hospital

  PRINCIPAL INVESTIGATOR

• In Joo Kim, M.D., Ph.D.

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 29, 2013
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

KR (1)