A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
研究概览
简要总结
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
详细描述
Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the procedures of this trial and provide written informed consent voluntarily;
- •Age ≥ 18 years, male or female;
- •Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
- •Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
- •HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.
排除标准
- •With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
- •Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
- •Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
- •Known treatment failure on pregabalin or gabapentin;
研究组 & 干预措施
JMKX000623
JMKX000623 for 12 weeks
干预措施: JMKX000623 (Drug)
JMKX000623
JMKX000623 for 12 weeks
干预措施: Placebo (Drug)
Pregabalin
Pregabalin for 12 weeks
干预措施: Pregabalin (Drug)
Pregabalin
Pregabalin for 12 weeks
干预措施: Placebo (Drug)
Placebo
placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
时间窗: baseline，Week 12
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]
次要结局
- Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)](baseline，Week 5)
- Adverse Events(baseline，Week 12)