A Randomized, Double-blind, Independent 3rd Party Unblind, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Anisodamine (654-II), 10mg, to Evaluate the Efficacy and Safety of Buscopan® Solution for Injection, 20mg (Intramuscularly) for the Treatment of Acute Gastric or Intestinal Spasm-like Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 20
- 主要终点
- PID From Pre-dose Baseline at 20 Minutes After First Injection.
研究概览
简要总结
The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like 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 70 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
Buscopan® (hyoscine butylbromide)
1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection
干预措施: Buscopan® (hyoscine butylbromide) (Drug)
654-II(anisodamine)
1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection
干预措施: 654-II (anisodamine) (Drug)
结局指标
主要结局
PID From Pre-dose Baseline at 20 Minutes After First Injection.
时间窗: Baseline and 20 minutes after the first injection
Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.
次要结局
- PID From Pre-dose Baseline at 10 Minutes After First Injection.(Baseline and 10 minutes after the first injection)
- Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection(120 minutes after the first injection)
- Proportion of Patients Who Need the Second Injection(20 minutes after the first injection.)
- PID From Pre-dose Baseline at 30 Minutes After First Injection.(Baseline and 30 minutes after the first injection)
- PID From Pre-dose Baseline at 60 Minutes After First Injection.(Baseline and 60 minutes after the first injection)
- PID From Pre-dose Baseline at 120 Minutes After First Injection.(Baseline and 120 minutes after the first injection)