Back to results

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

Primary Purpose

Diabetic Neuropathy

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

600㎍ of DA-3030 Injection

Placebo

About this trial

This is an interventional treatment trial for Diabetic Neuropathy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hanyang University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

600㎍ of DA-3030 Injection

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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)

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)

overnight pain score

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

Full Information

NCT ID

NCT01820715

First Posted

March 15, 2013

Last Updated

August 12, 2013

Sponsor

Dong-A Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01820715

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

600㎍ of DA-3030 Injection

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

600㎍ of DA-3030 Injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Time Frame

12 Weeks

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Average pain score

Description

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

Time Frame

12 Weeks

Title

Most severe pain score

Description

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

Time Frame

12 weeks

Title

overnight pain score

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: