EUCTR2017-003767-35-SE进行中（未招募）1 期
A randomised, double-blind, parallel group study comparing patient controlled analgesia with Penthrox® (methoxyflurane) versus placebo during colonoscopy - MEthoxyflurane in Acute coloNoScopy pain: MEANS randomised controlled trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1.Referred for colonoscopy for clinical indications or cancer screening
- •2.Males and females, age = 18 years.
- •3.Female Subjects less than one year post-menopausal must have a negative urine pregnancy test prior to the first dose of study medication, and be non-lactating.
- •4.Written informed consent obtained from the Subject indicating that they understand the purpose of, and procedures required, for the study and are willing to participate in it.
- •5.Ability to understand the use of the Penthrox (Methoxyflurane) inhaler.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1.Pregnancy or lactation period (women only)
- •2.Previous colorectal resections
- •3.Same-day bi-directional endoscopy
- •4.Subjects having a pain score (pain right now) > 2 as assessed by a NRS score (0 – 10) at baseline
- •5.Subjects with any condition e.g. extreme anxiety judged by the Investigator to interfere with correct administration of Penthrox (Methoxyflurane) inhaler
- •6.Diagnosed anxiety disorders
- •7.Concomitant treatment with psychotropic drugs including benzodiazepines
- •8.Active alcohol or drug abuse and/or history of opioid abuse
- •9.Renal impairment defined as creatinine >1.5 x ULN measured at screening
- •10.Subjects taking any potential nephrotoxic drugs (e.g. aminoglycosides)
- •11.Uncontrolled diabetes mellitus as evidenced by HbA1c > 8% at screening or known diabetic nephropathy
- •12.Evidence of clinically significant disease e.g. liver, cardiac, respiratory or malignant disease (e.g., ischemic heart disease, chronic obstructive pulmonary disease, chronic liver disease) based on Investigator assessment of medical notes and/or subject recall, physical examination, laboratory and ECG assessments conducted at screening with ASA 3 or higher
- •13.Previous possible allergy to the study medication by the subject or relative
- •14.Any history of hypersensitivity to fluorinated agents
- •15.Concomitant head injury
- •16.Unconsciousness
- •17.Personal or family history of malignant hyperthermia
- •18.Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
- •19.Subjects who are incapable of giving informed consent or complying with the protocol.
- •20.Subjects who have a history of showing signs of liver or kidney damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia.
- •21.Requiring treatment with any prohibited concomitant medications
- •22.Use of any premedication before the procedure e.g. with sedative or analgesic medications within 24 hours before colonoscopy
研究者
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