EUCTR2020-004118-37-DK进行中（未招募）1 期
A Phase 2/3, prospective, open-label trial evaluating the efficacy, safety, and pharmacokinetics of remimazolam for intravenous sedation in paediatric patients undergoing diagnostic and/or therapeutic procedures.
PAION UK Ltd0 个研究点目标入组 100 人开始时间: 2021年5月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent form and/or assent (if applicable) and willingness of patient and parent(s) to participate in the trial.
- •In European sites: Paediatric male or female patients, aged full term birth to <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial.
- •? Patient aged <2 years must not be dosed in European sites until adequate supporting data are available from juvenile toxicity studies.
- •Maximum planned duration of procedure: 2 hours
- •ASA Physical Status I-III
- •Planned spontaneous breathing during sedation
- •A female who is of child bearing potential (i.e. after menarche) and sexually active must use a highly effective method of birth control during the trial period (from the time of consent until all specified observations are completed)
- •Negative pregnancy test at screening and on treatment day. Only needs to be performed once if screening is on the same day as the treatment day.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Emergency procedures
- •Condition/procedure that requires planned airway control via endotracheal tube or LMA/IGEL insertion
- •Cranio-facial malformation, which would severely limit the possibilities for emergency airway rescue
- •Other abnormalities relating to the airway (including large tonsils and anatomical abnormalities of upper airway or lower airway) which may compromise emergency airway rescue
- •Known hypersensitivity to benzodiazepines, flumazenil, dextran or any of the ingredients of the IMP
- •Known paradoxical reactions to benzodiazepines
- •History of sleep apnoea
- •Active respiratory failure
- •Active neuromuscular disease
- •Active cardiac failure
- •Active hepatic failure
- •Pregnant or Breast-feeding females
- •Prohibited medication:
- •? Any investigational drug when taken within 30 days or less than 7 half-lives (whichever is longer) before Treatment Day.
- •? Any medication given for sedative purposes other than nitrous oxide and IMP on the Treatment Day
- •? (For full list of prohibited medication after randomisation please see Protocol)
- •Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason
研究者
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