A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 4
- 主要终点
- Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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
Sufentanil Tablet 30 mcg
A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
干预措施: Sufentanil Tablet 30 mcg (Drug)
Placebo Tablet
A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
干预措施: Placebo Tablet (Drug)
结局指标
主要结局
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
时间窗: 12 hours
The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
次要结局
- TOTPAR24(24 Hours)
- Time-weighted SPRID12(12 hours)
- Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).(24 hours)
- TOTPAR12(12 hours)
- Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population(Cumulative through 24 hours)
- Time-weighted SPRID24(24 hours)
- Patient Global Assessment(24 hours)
- Healthcare Professional Global Assessment(24 hours)
- Summed Pain Intensity Difference(1 hour)
- Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population(Cumulative through 12 hours)
- Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population(24 hours)