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Study of DA-9801 to Treat Diabetic Neuropathic Pain

Primary Purpose

Diabetic Neuropathies

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

DA-9801 300mg

DA-9801 600mg

DA-9801 900mg

Placebo

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Diabetic Neuropathies

Eligibility Criteria

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

Inclusion Criteria:

the age of 20 ~ 70
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 more for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

neuropathic pain due to other causes or another stronger pain other than neuropathic pain
abnormal in blood pressure, weight, ALT/AST, Serum creatinine
positive reaction in HIV, HBV, or HCV
experience of suicide try or Mental Illness Medical History
BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history

Sites / Locations

Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

DA-9801 300mg

DA-9801 600mg

DA-9801 900mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Difference in average 24-h pain intensity (Likert scale) between before and after IP administration

Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.

Secondary Outcome Measures

Inter-group difference in average 24-h pain intensity (Likert scale)

The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.

Most severe mean pain intensity (Likert Scale)

Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning.

Overnight pain intensity (Likert Scale)

Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.

Patient's Global Impression of improvement (1 point ~ 7 point)

Subject evaluated the level of symptom improvement during the visits after IP administration.

Clinical Global Impression of severity (1 point ~ 7 point)

Investigator evaluated the level of symptom severity when a subject visited the institution.

Average daily dose of acetaminophen

Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every

Full Information

NCT ID

NCT01813799

First Posted

March 13, 2013

Last Updated

April 14, 2019

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01813799

Brief Title

Study of DA-9801 to Treat Diabetic Neuropathic Pain

Official Title

A Multicenter, Placebo-controlled, Randomized, Double-blind, Phase II Clinical Trial With Diabetic Neuropathy Patients is Designed to Evaluate the Safety and Efficacy of the DA-9801 Tablet for Neuropathic Pain and to Decide Optimal Dose.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

November 2011 (Actual)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in the treatment of pain associated with diabetic neuropathy. Subjects will receive either 300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.

6. Conditions and Keywords

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

Diabetic Neuropathies

Keywords

Diabetic Neuropathies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DA-9801 300mg

Arm Type

Experimental

Arm Title

DA-9801 600mg

Arm Type

Experimental

Arm Title

DA-9801 900mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

DA-9801 300mg

Intervention Description

300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Intervention Type

Drug

Intervention Name(s)

DA-9801 600mg

Intervention Description

600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Intervention Type

Drug

Intervention Name(s)

DA-9801 900mg

Intervention Description

900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Primary Outcome Measure Information:

Title

Difference in average 24-h pain intensity (Likert scale) between before and after IP administration

Description

Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Inter-group difference in average 24-h pain intensity (Likert scale)

Description

The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.

Time Frame

8 weeks

Title

Most severe mean pain intensity (Likert Scale)

Description

Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning.

Time Frame

4, 8 weeks

Title

Overnight pain intensity (Likert Scale)

Description

Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.

Time Frame

4, 8 weeks

Title

Patient's Global Impression of improvement (1 point ~ 7 point)

Description

Subject evaluated the level of symptom improvement during the visits after IP administration.

Time Frame

4, 8 weeks

Title

Clinical Global Impression of severity (1 point ~ 7 point)

Description

Investigator evaluated the level of symptom severity when a subject visited the institution.

Time Frame

4, 8 weeks

Title

Average daily dose of acetaminophen

Description

Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every

Time Frame

everyday(-2 weeks~0), everyday(0~8 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: the age of 20 ~ 70 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 more for 24 hours evaluated with 11-point Likert scale Exclusion Criteria: neuropathic pain due to other causes or another stronger pain other than neuropathic pain abnormal in blood pressure, weight, ALT/AST, Serum creatinine positive reaction in HIV, HBV, or HCV experience of suicide try or Mental Illness Medical History BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history

Overall Study Officials: