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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DA-9801 300mg
干预措施: DA-9801 300mg (Drug)
DA-9801 600mg
干预措施: DA-9801 600mg (Drug)
DA-9801 900mg
干预措施: DA-9801 900mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
时间窗: 8 weeks
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.
次要结局
- Average daily dose of acetaminophen(everyday(-2 weeks~0), everyday(0~8 weeks))
- Inter-group difference in average 24-h pain intensity (Likert scale)(8 weeks)
- Most severe mean pain intensity (Likert Scale)(4, 8 weeks)
- Overnight pain intensity (Likert Scale)(4, 8 weeks)
- Patient's Global Impression of improvement (1 point ~ 7 point)(4, 8 weeks)
- Clinical Global Impression of severity (1 point ~ 7 point)(4, 8 weeks)