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MEOF-002 - Methoxyflurane AnalGesia for Paediatric InjuriEs (MAGPIE)

  • Research type

    Research Study

  • Full title

    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)

  • IRAS ID

    220282

  • Contact name

    Stuart Hartshorn

  • Contact email

    stuart.hartshorn@bch.nhs.uk

  • Sponsor organisation

    Medical Developments International Limited

  • Eudract number

    2016-004290-41

  • Duration of Study in the UK

    1 years, 9 months, 28 days

  • Research summary

    About 220 people will take part in this study (176 children of 6–11 years of age, and 44 adolescents of 12–17 years of age). The study will be conducted at approximately 10 hospitals in the United Kingdom (UK) and Republic of Ireland.

    The overall purpose of the study is to gain more information on how well methoxyflurane (PENTHROX®), the study drug, works at relieving pain in patients 6–17 years of age who are admitted to a hospital emergency department with a minor injury (known as trauma) and any side effects.

    This is a Phase 3 study, which means the study drug has already been given to other patients in other studies. Now, researchers need to learn more about the study drug when it is used in children of various ages and with different health needs. This study is being done to learn more about how best to use the study drug for patients in the future.

    Methoxyflurane (PENTHROX®), the study drug, is a licensed product in the UK. It is taken using a hand-held inhaler and is currently used in the emergency department to relieve pain in injured adults.

    The study drug will be compared to a placebo. A placebo looks the same as the medicine being studied but does not contain any active substance. Participants will have an equal chance (50:50) that they will be given either the study drug or placebo.

    This study will include screening and enrolment, followed by treatment and day 14 ± 2 day safety telephone follow-up post treatment. The procedure for screening and enrolment including obtaining consent/assent is to occur on the same day.

    MEOF-002 forms part of the Paediatric Investigation Plan (PIP) as agreed with the EMA (European Medicines Agency)’s Paediatric Committee (PDCO).

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    17/SC/0039

  • Date of REC Opinion

    11 Apr 2017

  • REC opinion

    Further Information Favourable Opinion