Diabetic Neuropathies
Conditions
Keywords
Diabetic Neuropathies
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.
Interventions
DRUGDA-9801 300mg
300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DRUGDA-9801 600mg
600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DRUGDA-9801 900mg
900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DRUGPlacebo
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in average 24-h pain intensity (Likert scale) between before and after IP administration | 8 weeks | Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Most severe mean pain intensity (Likert Scale) | 4, 8 weeks | 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) | 4, 8 weeks | Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning. |
| Inter-group difference in average 24-h pain intensity (Likert scale) | 8 weeks | The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups. |
| Clinical Global Impression of severity (1 point ~ 7 point) | 4, 8 weeks | Investigator evaluated the level of symptom severity when a subject visited the institution. |
| Average daily dose of acetaminophen | everyday(-2 weeks~0), everyday(0~8 weeks) | Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every |
| Patient's Global Impression of improvement (1 point ~ 7 point) | 4, 8 weeks | Subject evaluated the level of symptom improvement during the visits after IP administration. |
Countries
South Korea
Outcome results
None listed