Multinational, Multicenter, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Study of Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 191
- 试验地点
- 61
- 主要终点
- Change from baseline in the average daily pain intensity as measured by the 11-point NRS;
研究概览
简要总结
Primary Objective:
To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS).
Secondary Objectives:
- To compare the effects of SAR292833 with placebo on the change of neuropathic pain symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI);
- To evaluate the effects of SAR292833 in comparison to placebo on the change in pain intensity of mechanical allodynia;
- To investigate the safety and tolerability of SAR292833 in comparison to placebo;
- To investigate the pharmacokinetics (PK) and the relationships between main efficacy parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in patients with chronic peripheral neuropathic pain.
详细描述
Total study duration (from screening to last follow-up visit) is 9 weeks that includes a 3 week follow-up period.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR292833 dose level 1
Dose level 1 twice daily immediately after breakfast/dinner
干预措施: SAR292833 (Drug)
SAR292833 dose level 2
Dose level 2 twice daily immediately after breakfast/dinner
干预措施: SAR292833 (Drug)
Placebo
Placebo (for SAR292833) twice daily immediately after breakfast/dinner
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in the average daily pain intensity as measured by the 11-point NRS;
时间窗: Baseline to 4 weeks
The average daily pain intensity is the mean of the last consecutive 7 days.
次要结局
- Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline(Baseline to 4 weeks)
- Change in intensity of the mechanical allodynia after 4 weeks treatment compared to baseline using visual analog scale (VAS)(Baseline to 4 weeks)
- Amount of and time to first rescue medication intake during the treatment period.(4 weeks)
- Percentage of patients with reduction in pain intensity of at least 30% and 50% at endpoint compared to baseline derived from the primary efficacy endpoint;(Baseline to 4 weeks)
- Change in Daily Sleep Interference Score (DSIS), clinical global impression of change (PGIC and CGIC).(4 weeks)