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    Summary
    EudraCT Number:2016-004290-41
    Sponsor's Protocol Code Number:MEOF-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-01-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-004290-41
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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)
    A.3.2Name or abbreviated title of the trial where available
    MAGPIE
    A.4.1Sponsor's protocol code numberMEOF-002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/264/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical Developments International Limited
    B.1.3.4CountryAustralia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support Medical Developments International
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Developments International Limited
    B.5.2Functional name of contact pointDirector, Scientific Affairs
    B.5.3 Address:
    B.5.3.1Street Address4 Caribbean Drive
    B.5.3.2Town/ cityScoresby Victoria
    B.5.3.3Post code3179
    B.5.3.4CountryAustralia
    B.5.6E-mailregulatory@medicaldev.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name PENTHROX
    D.2.1.1.2Name of the Marketing Authorisation holderMedical Developements UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePENTHROX
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmethoxyflurane
    D.3.9.1CAS number 76-38-0
    D.3.9.3Other descriptive namePENTHROX
    D.3.9.4EV Substance CodeSUB32438
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number99.9%
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation vapour
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute pain in paediatric patients
    E.1.1.1Medical condition in easily understood language
    pain
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066714
    E.1.2Term Acute pain
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PENTHROX® (methoxyflurane) for the treatment of acute pain in paediatric patients presenting to an Emergency Department (ED) with minor trauma
    E.2.2Secondary objectives of the trial
    To evaluate the safety of PENTHROX® (methoxyflurane) for the treatment of acute pain in paediatric patients presenting to an ED with minor trauma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.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 60 to 80 mm as measured using VAS or 6 to 8 using Wong Baker FACES® Pain Rating scale.
    E.4Principal exclusion criteria
    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 self-administering the study drug using the PENTHROX® inhaler.
    5. Treatment with any analgesic agent within 5 hours prior to presentation to ED, except Entonox (50% nitrous oxide and 50% oxygen mixture) which is prohibited within 30 minutes prior to arrival at ED, diclofenac which is prohibited within 8 hours prior to presentation to ED or oral morphine which is prohibited within 10 hours prior to presentation to ED.
    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.Known significant cardiovascular disease (e.g., pathological arrhythmia).
    18.Inability to participate in telephonic follow-up on (Day 14 ± 2 days) as per study requirement.
    E.5 End points
    E.5.1Primary end point(s)
    •Difference in pain intensity between active drug and placebo as measured by VAS from baseline to 15 minutes after the commencement of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 minutes after commencement of treatment
    E.5.2Secondary end point(s)
    •Responder analysis – number and percentage of responders, who achieve 30% reduction in VAS score compared to baseline, at 15 minutes.
    •Responder analysis – exploratory: number and percentage of responders who achieve 30% reduction in VAS score compared to baseline at 5, 10 and 20 minutes.
    •Change in pain intensity as measured using VAS from baseline to 5, 10, 15, 20 and 30 minutes, followed by a 30-minute interval thereafter until the point of ED discharge/in-patient admission decision.
    •Rescue medication requested within 20 minutes of start of treatment and any time during treatment.
    •The time to request for rescue medication.
    •The time to first pain relief.
    •The number of inhalations taken before first pain relief and whether the patient covered the hole in the Inhaler during inhalation.
    •Global medication performance assessment by patient, clinician and research nurse: 0 = poor to 4 = excellent, measured after completion of treatment.
    •Evaluation of adverse events (AEs) experienced during treatment, not associated with the underlying minor trauma.
    •Evaluation for any change in vital signs and sedation score during treatment.
    •Evaluation of AEs at 14 ± 2 days following ED discharge using follow-up questionnaire that includes high output nephrotoxicity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the descriptions of the endpoints above.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    once the last patient had had their telephonic follow up on Day 14+/2
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 222
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 156
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 66
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric population
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state174
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Paediatric Emergency Research in the UK and Ireland (PERUKI)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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