Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Vertebral Fracture Associated With Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]
研究概览
简要总结
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture.
Secondary objectives were:
- to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
- to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.
详细描述
The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.
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
- 40 Years 至 80 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
REGN475/SAR164877
REGN475/SAR164877, single injection, dose depending on the participant's body weight
干预措施: REGN475/SAR164877 (Drug)
Placebo
Placebo (for REGN475/SAR164877), single injection
干预措施: Placebo (for REGN475/SAR164877) (Drug)
结局指标
主要结局
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]
时间窗: baseline and 4 weeks after injection
The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit. The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4.
次要结局
- Mean change from baseline in pain intensity as assessed by PI-NRS(baseline and every other weeks up to 12 weeks after injection)
- Percentage of pain-free days (score "0" pain on PI-NRS)(12 weeks)
- Percentage of days with rescue analgesia use(12 weeks)
- Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score(baseline and 4, 8, 12 weeks)
- Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score(baseline and 4, 8, 12 weeks)
- Patient Global Impression of Change [PGIC] score(4, 8, 12 weeks)
- Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity(up to 12 weeks after injection)
- Pharmacokinetic: REGN475/SAR164877 serum concentration(12 weeks)