A Multi-centre, Double-blind, Randomised, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Topically Applied Hyperemisation-inducing Ointment (2cm Ointment Line Per Application; up to 3 Times Daily for up to 4 Days) Containing 2.5% Nicoboxil/0.4% Nonivamide Versus 2.5% Nicoboxil, 0.4% Nonivamide and Placebo in Patients 18 to 65 Years of Age With Acute Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 37
- 主要终点
- Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application
研究概览
简要总结
The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back 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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 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
placebo
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
干预措施: placebo matching nonivamide + nicoboxil (Drug)
nonivamide + nicoboxil (Finalgon)
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
干预措施: nonivamide + nicoboxil (Finalgon) (Drug)
nicoboxil
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
干预措施: nicoboxil (Drug)
nonivamide
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
干预措施: nonivamide (Drug)
结局指标
主要结局
Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application
时间窗: Baseline and 8 hours after first ointment application
Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.
次要结局
- Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application(Baseline and 4 hours after first ointment application)
- Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day(Baseline and 1 to 4 days)
- Patient Assessment of Efficacy on the Last Individual Treatment Day(1 to 4 days)