Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain (a Single-centre, Partially Double-blinded, Randomised, placebo-and Active Comparator-controlled, Single-dose, Parallel-group Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SPID0-8h
研究概览
简要总结
To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.
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 55 Years（Adult）
- 性别
- Male
- 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
BI 1026706 low dose
BI 1026706 low dose
干预措施: Placebo to BI 1026706 solution (Drug)
BI 1026706 low dose
BI 1026706 low dose
干预措施: BI 1026706 (Drug)
BI 1026706 low dose
BI 1026706 low dose
干预措施: Placebo to BI 1026706 tablet (Drug)
BI 1026706 high dose
BI 1026706 high dose
干预措施: BI 1026706 (Drug)
BI 1026706 high dose
BI 1026706 high dose
干预措施: Placebo to BI 1026706 tablet (Drug)
Placebo reference
Placebo reference
干预措施: Placebo to BI 1026706 solution (Drug)
Placebo reference
Placebo reference
干预措施: Placebo to BI 1026706 tablet (Drug)
Celecoxib reference
Celecoxib capsule
干预措施: Placebo to BI 1026706 solution (Drug)
Celecoxib reference
Celecoxib capsule
干预措施: Celecoxib (Drug)
结局指标
主要结局
SPID0-8h
时间窗: up to 8 hours post drug administration
Time-weighted sum of pain intensity difference (PID) from 0 to 8 hours post drug administration (SPID0-8h). SPID0-8h: possible range (-400; 800). The greater SPID0-8 the greater the reduction of pain intensity over the first 8 hours post drug administration.
次要结局
- Time to Meaningful Pain Relief(up to 10 hours post drug administration)
- Time to First Dose of Rescue Medication(up to 10 hours post drug administration)
- SPID0-2h(up to 2 hours post drug administration)
- Percentage of Patients With Drug-related Adverse Events(From first drug administration until 3 days after last drug administration, upto 4 days)
- TOTPAR0-8h(up to 8 hours post drug administration)