Study of DA-9801 to Treat Diabetic Neuropathic Pain

Dong-A ST Co., Ltd.128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

128

Conditions

Diabetic Neuropathies

Interventions

DA-9801 300mgDRUG

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

DA-9801 600mgDRUG

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

DA-9801 900mgDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Chonbuk National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 4, 8 weeks

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.

Time frame: 4, 8 weeks

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

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

Time frame: 4, 8 weeks

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

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

Time frame: 4, 8 weeks

Average daily dose of acetaminophen

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

Data from ClinicalTrials.gov

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