A Multinational, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Finalgon® Cream (1.08% Nicoboxil/ 0.17% Nonivamide) in the Treatment of Acute Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 8
- 主要终点
- Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)
研究概览
简要总结
To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in patients with acute low back pain. To investigate the safety and tolerability of repeated use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).
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
2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
干预措施: placebo matching nonivamide + nicoboxil (Finalgon cream) (Drug)
nonivamide + nicoboxil (Finalgon cream)
2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
干预措施: nonivamide + nicoboxil (Finalgon cream) (Drug)
结局指标
主要结局
Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)
时间窗: Baseline and 8 hours after trial medication 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 trial medication application. The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'. PID8h= Pain intensity (PI)8h - PI(baseline). Means reported are the adjusted means.
次要结局
- Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)(Baseline and 4 hours after trial medication application)
- Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day(Baseline and 1 to 4 days)
- Patient's Assessment of the Efficacy on the Last Individual Treatment Day(1 to 4 days)