NCT00791024已完成1 期
Phase One Study and Two of a New Method for Local Analgesia
Ove Andersen1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
Aim: To examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.
详细描述
A phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). The second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Patients admitted for adipositas surgery
- •Patients who attend for oesophagogastroduodenoscopy.
排除标准
- •Severe psychiatric diseases
- •Alcohol abuse
研究组 & 干预措施
single arm
Experimental
干预措施: CRC-Pharma 001 (Drug)
single arm
Experimental
干预措施: lidocaine suspension (Drug)
结局指标
主要结局
VAS score
时间窗: at day O and 3
次要结局
- Questionnaire( examiner and patient)(performed at day 0 and 3)
研究者
Ove Andersen
Research director
Hvidovre University Hospital
研究点 (1)
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