NCT01820715已完成1 期
A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test
研究概览
简要总结
A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.
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
- •20≤ Age ≤ 70
- •Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale
排除标准
- •Neuropathic pain due to other causes
- •Another stronger pain other than neuropathic pain
- •Abnormality in blood pressure, weight
- •Positive reaction in HIV, HBV or HCV
- •A medical history of mental illness within 6 months
- •The grade of BDI(Beck Depression Inventory) exceeds 21 points
- •History of drug/alcohol abuse
研究组 & 干预措施
600㎍ of DA-3030 Injection
Experimental
600㎍ of DA-3030 is injected once a day, for 5 continuous days.
干预措施: 600㎍ of DA-3030 Injection (Drug)
Placebo
Placebo Comparator
Placebo(a salin drip) is injected once a day, for 5 continuous days.
干预措施: Placebo (Drug)
结局指标
主要结局
Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test
时间窗: 12 Weeks
Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event
时间窗: 12 weeks
次要结局
- Average pain score(12 Weeks)
- Most severe pain score(12 weeks)
- overnight pain score(12 weeks)
研究者
研究点 (1)
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