Study of DA-9801 to Treat Diabetic Neuropathic Pain

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: DA-9801 300mg
* Drug: DA-9801 600mg
* Drug: DA-9801 900mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-9801 300mg<br> | Drug: DA-9801 300mg<br>* 300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.<br>|
| Experimental: DA-9801 600mg<br> | Drug: DA-9801 600mg<br>* 600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.<br>|
| Experimental: DA-9801 900mg<br> | Drug: DA-9801 900mg<br>* 900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | everyday(-2 weeks 0), everyday(0 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Neuropathies