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    Summary
    EudraCT Number:2017-000338-70
    Sponsor's Protocol Code Number:MR311-3502
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-000338-70
    A.3Full title of the trial
    A phase IIIb open randomized clinical trial to compare pain relief between methoxyflurane and standard of care for treating patients with trauma pain in Spanish emergency units.
    Ensayo clínico fase IIIb, aleatorizado, abierto, para evaluar el alivio del dolor con metoxiflurano inhalado, en comparación con el protocolo actual para el tratamiento del dolor de origen traumático en adultos atendidos en las unidades de urgencia españolas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate pain relief of the traumatic pain of methoxyflurane against analgesic treatment used in the usual clinical practice in patients with trauma treated at Spanish emergency units.
    Ensayo clínico para evaluar el alivio del dolor con metoxiflurano en comparación con el tratamiento analgésico utilizado en la práctica clínica habitual en pacientes con trauma atendidos en unidades de urgencia españoles.
    A.3.2Name or abbreviated title of the trial where available
    INMEDIATE
    INMEDIATE
    A.4.1Sponsor's protocol code numberMR311-3502
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMundipharma Pharmaceuticals, S.L.
    B.1.3.4CountrySpain
    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 supportMundipharma Pharmaceuticals, S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number003491 2071466
    B.5.6E-mailmaria.posada@idipaz.es
    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 3 ml inhalation vapour liquid
    D.2.1.1.2Name of the Marketing Authorisation holderMedical Developments UK Ltd.
    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 3ml vapour liquid
    D.3.2Product code ME-MEOTH
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    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.3.9.2Current sponsor codeME-MEOTH
    D.3.9.4EV Substance CodeSUB08858MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Trauma Pain
    Dolor Traumático
    E.1.1.1Medical condition in easily understood language
    Trauma Pain
    Dolor Traumático
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10065016
    E.1.2Term Post-traumatic pain
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10044461
    E.1.2Term Trauma
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Change in mean pain intensity over 20 min from start of administration (STA) and time to first pain relief
    Cambio en la intensidad media del dolor durante 20 min desde el inicio de la administración (STA) y el tiempo hasta el primer alivio del dolor
    E.2.2Secondary objectives of the trial
    - Analgesic efectiveness
    - Speed of action of analgesia (from randomisation (R) to STA)
    - Preparation + administration time and complexity
    - Safety
    - Cost
    - Investigator and patients satisfaction
    - Patient and investigators fulfillement of expectations
    - Patients Global impression of change
    - Request of rescue medication
    - Treatment cost per pain relief by time unit
    - Time from R and STA to pain relief
    - Number of patients achieving pain intensity NRS0-10= <3
    - Change in pain intensity from STA to time> 20 min
    - Request of rescue medication
    - Safety: rates of Adverse Events
    - Efectividad analgésica
    - Velocidad de acción analgésica
    - Tiempo de preparación y administración y complejidad
    - Seguridad
    - Coste
    - Satisfacción de investigadores y pacientes
    - Cumplimentación de expectativas de pacientes e investigadores
    - Imprescindible clínica global del cambio
    - Tiempo desde la aleatorización (R) hasta el alivio del dolor
    - Número de pacientes que alcanzan la intensidad de dolor NRS0-10= <3
    - Cambio en la intensidad de dolor > 20 min tras STA
    - Necesidad de medicación de rescate
    - Seguridad: tasas de efectos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    - Adult patients: ≥ 18 years of age
    - Moderate to severe pain (NRS0-10 ≥ 4) secondary to trauma
    - Without anticipating surgery due to the trauma, requiring hospitalization (hospital stay ≥ 12h)
    - Conscious patient.
    - Giving informed consent in writing
    - Con edad ≥ a 18 años de edad
    - Con dolor leve-moderado (EV0-10 ≥4), secundario a traumatismo.
    - Que en el triaje no se prevea intervención quirúrgica debido al traumatismo, requiriendo ingreso hospitalario (estancia ≥ 12 h)
    - Pacientes conscientes en el momento de su inclusión en el estudio.
    - Pacientes que otorguen su consentimiento informado por escrito
    E.4Principal exclusion criteria
    - Hypersensitivity to Metoxiflurane or any fluorinated anaesthetic.
    - Malignant hyperthermia: patients with known or genetically susceptible to malignant
    hyperthermia or a history of severe adverse reactions in either patient or relatives.
    - Patients who have a history of showing signs of liver damage after previous Metoxiflurane use or
    halogenated hydrocarbon anaesthesia
    - Known clinically significant renal impairment
    - Known pregnant or likely to be pregnant women at the time of inclusion.
    - Clinically evident cardiovascular instability
    - Clinically evident respiratory depression
    - Patients taken any analgesic for the traumatic pain before inclusion
    - Altered level of consciousness due to any cause, including head injury, drugs or alcohol
    - Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain
    intensity
    - Patients to be unable to understand the purpose of the study and perform self-assessments,
    following investigator’s criteria.
    - Participation in another clinical trial within 30 days prior to randomization.
    -Pacientes con:
    *hipersensibilidad a metoxiflurano u otro anestésico fluorado,
    *hipertermia maligna o genéticamente susceptibles a la hipertermia maligna o con un historial de reacciones adversas severas tanto del paciente como de sus familiares,
    *historia de daños hepático tras el uso previo de metoxiflurano o hidrocarburos halogenados anestésicos,
    *insuficiencia renal clínicamente significativa ,
    *inestabilidad cardiovascular clínicamente evidente ,
    *depresión respiratoria clínicamente evidente,
    *alteración de la consciencia debido a cualquier caso, incluyendo daño en la cabeza, drogas o alcohol,
    *enfermedades degenerativas, enfermedad mental u otros trastornos que podrían afectar la capacidad de valorar la intensidad del dolor
    - Pacientes bajo tratamiento analgésico debido al dolor de origen traumático, previo a la inclusión en el estudio.
    - Mujeres embarazadas o que sospechen que pueden estarlo en el momento de su inclusión en el estudio.
    - Pacientes que a criterio del investigador sean incapaces de comprender el objetivo del estudio y realizar las autoevaluaciones
    - Pacientes que hayan participado en otro ensayo clínico hasta 30 días antes de su inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Pain Intensity measure by Numeric Scale (0-10)
    - Intensidad de dolor medido por una escala numérica (0-10)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 0, 3, 5, 10, 15 and 20 minutes after medicine administration and at discharge time
    A los 0, 3, 5, 10, 15 y 20 minutos después de la administración de medicación y al alta hospitalaria
    E.5.2Secondary end point(s)
    - Investigator and patients satisfaction measured as convenience, treatment efficacy and adverse event
    - Patients and investigators' fulfillment of expectation:
    - Patients' Globlal impression of change.
    - Rescue Medication
    - Adverse Events during the study
    - Total time required in the treatment, as well as the fungible materials used and their cost.
    - Satisfacción de investigadores y pacientes, con la comodidad, eficacia y efectos adversos del tratamiento
    - Cumplimiento de expectativas del investigador y paciente:
    - Impresión clínica Global del cambio evaluada por el paciente
    - Uso de medicación de rescate
    - Eventos Adversos acaecidos durante el estudio
    - Tiempo total requerido en el tratamiento, así como los materiales fungibles usados y sus costes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 0, 3, 5, 10, 15, 20, 30, 40, 50 and 60 minutes after medicine administration, at hopital discharge and 14 days (+/2) after hospital discharge (this last time only for safety data)
    A los 0, 3, 5, 10, 15, 20, 30, 40, 50 y 60 minutos después de la administración de medicación, al alta hospitalaria, hasta 14 días (+/- 2) depués del alta hospitalaria.
    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 Yes
    E.6.13.1Other scope of the trial description
    Health economic and outcome Research.
    Economía sanitaria y resultados de investigación
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cualquier analgésico usado en práctica clínica habitual
    Any analgesic used following Standar of Care of the Hospital
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LPLV
    Ultimo paciente, última visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 310
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state310
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 310
    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)
    NA
    NA
    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 Spanish Clinical Research Network (SCReN)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-02
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