Study of DA-9801 to Treat Diabetic Neuropathic Pain
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DA-9801 300mg
|
Drug: DA-9801 300mg
300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
|
| Experimental: DA-9801 600mg
|
Drug: DA-9801 600mg
600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
|
| Experimental: DA-9801 900mg
|
Drug: DA-9801 900mg
900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
the age of 20 ~ 70
-
Type I or Type II Diabetes
-
HbA1c ≤11%
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Patients with diabetic neuropathic pain for at least 3 months
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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
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abnormal in blood pressure, weight, ALT/AST, Serum creatinine
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chonbuk National University Hospital | Jeonju | Korea, Republic of | 561-712 |
Sponsors and Collaborators
- Dong-A ST Co., Ltd.
Investigators
- Principal Investigator: Bongyeon Cha, M.D., The Catholic University of Korea
- Principal Investigator: Hyeok Sang Gwon, M.D., Catholic University Yeouido St. Mary's Hopspital
- Principal Investigator: Inkyung Jeong, M.D., Gangdong Kyunghee University Hospital
- Principal Investigator: Ji Hyeon Lee, M.D., Daegu Catholic University Medical Center
- Principal Investigator: Jeong Guk Kim, M.D., Kyungpook National University Hospital
- Principal Investigator: In Ju Kim, M.D., Busan National University Hospital
- Principal Investigator: Young Min Cho, M.D., Seoul National University Hospital
- Principal Investigator: Chun Hee Jung, M.D., Yonsei University Wonju Christian Hospital
- Principal Investigator: Jyeong Hyeon Park, M.D., Inje University
- Principal Investigator: Mun Seok Nam, M.D., Inha University Hospital
- Principal Investigator: Dong Hyeok Cho, M.D., Chonnam National University Hospital
- Principal Investigator: Min Kyong Moon, M.D., SMG-SNU Boramae Medical Center
- Principal Investigator: Chong Hwa Kim, M.D., Sejong Hospital
- Principal Investigator: Kwan Pyo Ko, M.D., Jeju National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DA9801_DN_II