EUCTR2016-004290-41-IE进行中（未招募）1 期
A randomised, double-blind, multicentre, placebo controlled study to evaluate the safety and efficacy of methoxyflurane (PENTHROX®) for the treatment of acute pain in children and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department with minor trauma) - MAGPIE
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
- 256
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
- •11.Patients aged 6 to less than 18 years.
- •2.Attending ED following minor trauma.
- •3.Evidence of signed and dated informed consent/assent document
- •indicating that the patient (and/or a parent/legal guardian) has been
- •informed of all pertinent aspects of the study.
- •4.Pain scores 55-85 mm as measured using VAS or 6 to 8 using Wong
- •Baker FACES® Pain Rating scale.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 256
- •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
- •1.Critical, life- or limb-threatening condition requiring immediate
- •management.
- •2.Open fractures.
- •3.Patients with any other clinical condition that may, in the opinion of
- •the Investigator, impact the patient's ability to participate in the study,
- •or the study results.
- •4.Patients deemed not cognitively capable of effectively selfadministering
- •the study drug using the PENTHROX® inhaler.
- •5. .Treatment with any analgesic agent within 5 hours prior to randomisation, except Entonox (50% nitrous oxide and 50% oxygen mixture) which is prohibited within 30 minutes prior to randomisation, diclofenac which is prohibited within 8 hours prior to randomisation or oral morphine
- •which is prohibited within 10 hours prior to randomisation.
- •6.Patients with chronic pain.
- •7.Patients having received an IMP in the preceding 3 months.
- •8.Known pregnancy or breastfeeding females.
- •9.Personal or familial hypersensitivity to PENTHROX® or any fluorinated anaesthetics.
- •10.Patients requiring oxygen therapy.
- •11.Patients with known or genetic susceptibility to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
- •12.Clinically evident respiratory depression.
- •13.Previous use of methoxyflurane (including as an IMP).
- •14.History of signs of liver damage including after previous PENTHROX® (methoxyflurane) use or halogenated hydrocarbon anaesthesia.
- •15.Known significant renal impairment.
- •16.Altered level of consciousness due to any cause including head injury, drugs, or alcohol.
- •17.Clinically evident cardiovascular instability(e.g., pathological arrhythmia).
- •18.Inability to participate in telephonic follow-up on (Day 14 ± 2 days) as per study requirement.
研究者
相似试验
进行中（未招募）
1 期
To evaluate the safety and efficacy of methoxyflurane (PENTHROX®) for the treatment of pain in children and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department with minor trauma)acute pain in paediatric patientsMedDRA version: 20.1Level: LLTClassification code 10066714Term: Acute painSystem Organ Class: 100000004867EUCTR2016-004290-41-GBMedical Developments International Limited220
进行中（未招募）
不适用
ot applicableSubjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852EUCTR2011-002901-31-HUMundipharma Research GmbH & Co. KG210
进行中（未招募）
1 期
A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated paiSubjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852EUCTR2011-002901-31-GBMundipharma Research GmbH & Co. KG202
进行中（未招募）
1 期
ot applicableSubjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disordersEUCTR2011-002901-31-ESMundipharma Research GmbH & Co. KG202
进行中（未招募）
不适用
ot applicableSubjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852EUCTR2011-002901-31-CZMundipharma Research GmbH & Co. KG210