An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy
研究概览
简要总结
The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 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
- •Painful distal symmetric polyneuropathy
- •Average daily pain score is great than or equal to 4
排除标准
- •HbA1c greater than 9.0
研究组 & 干预措施
DS-5565 Low Dose
DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
干预措施: DS-5565 (Drug)
DS-5565 Middle Dose
DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
干预措施: DS-5565 (Drug)
DS-5565 High Dose
DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
干预措施: DS-5565 (Drug)
Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
干预措施: Placebo (Drug)
Pregabalin
Pregabalin capsules 300mg/day administered in 2 doses
干预措施: Pregabalin capsules (Drug)
结局指标
主要结局
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy
时间窗: Baseline to Week 7 postdose
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo.
次要结局
- Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy(at Week 7 postdose)