NCT04094662已完成3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 40
- 主要终点
- Average Daily Pain Score (ADPS)
研究概览
简要总结
Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.
详细描述
The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Type 1 or type 2 diabetes mellitus at screening
- •Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)
排除标准
- •HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening
- •Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
- •Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
- •Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
- •Major psychiatric disorders at screening or randomization
- •Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening
研究组 & 干预措施
Mirogabalin
Experimental
Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
干预措施: Mirogabalin (Drug)
Placebo
Placebo Comparator
Placebo (14-weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Average Daily Pain Score (ADPS)
时间窗: Baseline to Week 14
The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores.
次要结局
- Patient Global Impression of Change(at Week 14)
- ADPS responder rate(at Week 14)
- Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)(at Week 14)
- Average Daily Sleep Interference score (ADSIS)(at Week 14)
- Medical Outcome Study (MOS) sleep scale(at Week 14)
- Five Level EuroQol-5D (EQ-5D) version(at Week 14)
研究者
研究点 (40)
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