2025-521354-42-00招募中2 期
A randomized, double-blind crossover study to investigate the analgesic efficacy of the bradykinin (B2) antagonist icatibant for propofol injection pain in healthy adult participants.
Oslo University Hospital HF1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年8月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Area under the curve of Visual Analog Scale pain ≥ 30 mm (0-100 mm) - AUCVAS≥30
研究概览
简要总结
Determine the analgesic efficacy of icatibant vs placebo in a propofol injection pain model
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The participant is overtly healthy as determined by medical evaluation including medical history and physical examination
- •Participant is ≥ 18 and < 50 years of age
- •Highly sensitive urine pregnancy test is negative for WOCBP
- •The participant must give a signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •The participant has participated in the PropPain study (EU CT 2024-514307-34-01) and obtained a max electronic Visual Analog Scale (VAS) pain ≥30 mm
排除标准
- •Known allergy or intolerance to the study intervention icatibant, or to propofol
- •Any condition that in the view of the investigators would suggest that the patient is unable to comply with the study protocol and procedures.
- •Known allergy or intolerance to eggs, soya or peanuts
- •Known neurological illness (e.g. epilepsy)
- •BMI is <16 and ≥30
- •Use of analgesics or alcohol the last 24 h before the study interventions
- •The participant is breastfeeding
- •The participant uses other medication(s) incompatible with the simultaneous use of propofol (e.g. benzodiazepines, hypnotics, narcotics, excessive alcohol use)
- •Participation in other clinical studies within the last two months before study intervention (except the related study mentioned above)
- •Not meeting the rules of fasting according to the protocol
结局指标
主要结局
Area under the curve of Visual Analog Scale pain ≥ 30 mm (0-100 mm) - AUCVAS≥30
Area under the curve of Visual Analog Scale pain ≥ 30 mm (0-100 mm) - AUCVAS≥30
次要结局
- Max electronic Visual Analog Scale (VAS) pain (0-100 mm)
研究者
Bjarte Onsrud
Scientific
Oslo University Hospital HF
研究点 (1)
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