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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-004469-28
    Sponsor's Protocol Code Number:MR311-4501
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-004469-28
    A.3Full title of the trial
    Multicentre, randomised, double-blind study assessing the efficacy and safety of Penthrox® combined with a standard analgesia (SoC) in comparison to a placebo combined with a standard analgesia (SoC) in adult patients admitted to the Emergency Department with moderate to severe pain associated with trauma
    Etude multicentrique, randomisée, en double aveugle évaluant l'efficacité et la tolérance de Penthrox® associé à une analgésie standard (SoC) en comparaison au placebo associé à une analgésie standard (SoC) chez des patients adultes admis en service d'urgence avec des douleurs modérées à sévères associées à un traumatisme
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study assessing the efficacy and safety of Penthrox® combined with a standard analgesia in comparison to a placebo combined with a standard analgesia in adult patients admitted to the Emergency Department with moderate to severe pain associated with trauma
    Etude évaluant l'efficacité et la tolérance de Penthrox® associé à une analgésie standard en comparaison au placebo associé à une analgésie standard chez des patients adultes admis en service d'urgence avec des douleurs modérées à sévères associées à un traumatisme
    A.3.2Name or abbreviated title of the trial where available
    Pen ASAP
    Pen ASAP
    A.4.1Sponsor's protocol code numberMR311-4501
    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
    B.1.3.4CountryFrance
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMUNDIPHARMA
    B.5.2Functional name of contact pointResponsable médical
    B.5.3 Address:
    B.5.3.1Street AddressTour Cristal / 7-11 Quai André Citroën
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75015
    B.5.3.4CountryFrance
    B.5.6E-mailBerangere.Chomier@mundipharma.fr
    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 liquide avec inhalateur (METHOXYFLURANE)
    D.2.1.1.2Name of the Marketing Authorisation holderMUNDIPHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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, liquid
    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
    Emergency relief of moderate to severe pain associated with trauma in conscious adult patients
    Soulagement d’urgence des douleurs modérées à sévères associées à un traumatisme chez des patients adultes conscients.
    E.1.1.1Medical condition in easily understood language
    Emergency relief of moderate to severe pain associated with trauma
    Soulagement d’urgence des douleurs modérées à sévères associées à un traumatisme
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10044461
    E.1.2Term Trauma
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the reduction in time until pain relief of the combination of Penthrox® + standard analgesic (SoC) versus placebo + standard analgesic (SoC) in adult patients admitted into emergency departments with moderate to severe pain associated with a trauma.
    Démontrer la diminution du délai de soulagement de la douleur de l’association Penthrox® + analgésie standard (SoC) versus placebo + analgésie standard (SoC) chez des patients adultes admis en service d’urgences avec une douleur modérée à sévère associée à un traumatisme.
    E.2.2Secondary objectives of the trial
    - Demonstrate a greater reduction of the pain score (measured on a VAS) of Penthrox® + SoC versus placebo + SoC
    - Compare the safety of Penthrox® + SoC to placebo + SoC
    - Assess patient sedation
    - Describe the SoC and concomitant analgesic treatments
    - Assess the patient/physician/nurse satisfaction (Overall performance of the drug)
    - Measure the duration of the emergency department stay.
    - Assess the time until medical decision to discharge
    - Démontrer une réduction supérieure du score de douleur (mesuré sur une EVA) de Penthrox® + SoC versus placebo + SoC
    - Comparer la tolérance de Penthrox® + SoC au placebo + SoC
    - Évaluation de la sédation du patient
    - Description du SoC et des traitements antalgiques concomitants
    - Évaluation de la satisfaction du patient/médecin/infirmière (Performance globale du médicament)
    - Mesure de la durée de séjour au sein du service des urgences.
    - Evaluation du temps écoulé jusqu’à la décision médicale de sortie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged 18 or older
    2. Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study
    3. Patients admitted to the emergency department due to a trauma
    4. Patients having a pain score ≥ 4 measured using a numerical scale (NS) at the time of admission to emergency departments
    5. Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation
    1. Hommes ou femmes âgés de 18 ans ou plus
    2. Patients (et en situation d’urgence, parent ou proche) ayant daté et signé leur consentement éclairé à la participation à l’étude
    3. Patients admis au service des urgences en raison d’un traumatisme
    4. Patients ayant un score de douleur ≥ 4 mesuré en utilisant une échelle numérique (EN) au moment de l'admission au service des urgences
    5. Patients ayant un score de douleur ≥ 40 mesuré à l'aide de l’EVA au moment de la randomisation
    E.4Principal exclusion criteria
    1. Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;
    2. Impaired consciousness regardless of the cause, including head trauma or drug or alcohol consumption;
    3. Acute medicinal or alcohol intoxication, according to the investigator;
    4. Known pregnancy or lactation;
    5. Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;
    6. Treatment with nitrous oxide within 5 hours before presentation at the emergency department;
    7. Use of analgesics for chronic pain;
    8. Prior use of Penthrox®;
    9. Use of an investigational product one month before presentation at the emergency department;
    10. Hypersensitivity to Penthrox® or any other fluoridated anesthetic;
    11. Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions;
    12. Clinical evidence of respiratory depression;
    13. Clinical evidence of cardiovascular instability;
    14. Clinical renal or hepatic damage, according to the investigator, pre-existing or known;
    15. Presence of any other clinical condition that can, according to the investigator’s opinion, have an impact on the patient's ability to participate in the study or the results of the study.
    1. Affections mettant en jeu le pronostic vital des patients nécessitant une admission immédiate au bloc opératoire ou à l'unité de soins intensifs ;
    2. Altération du niveau de conscience quelle qu’en soit la cause, y compris traumatisme crânien, consommation de drogues ou d'alcool ;
    3. Intoxication aiguë médicamenteuse ou due à l'alcool, selon l’investigateur ;
    4. Grossesse ou allaitement connu ;
    5. Traitement analgésique dans les 5 heures (8h pour le diclofenac sodique) précédents l’admission à l’exception du paracétamol qui est autorisé ;
    6. Traitement avec du protoxyde d’azote dans les 5 heures avant la présentation au service des urgences ;
    7. Utilisation d’analgésiques pour la douleur chronique ;
    8. Utilisation antérieure de Penthrox® ;
    9. Utilisation d'un produit expérimental un mois avant la présentation au service d'urgences ;
    10. Hypersensibilité à Penthrox® ou tout autre anesthésique fluoré ;
    11. Hyperthermie maligne : hyperthermie maligne connue ou prédisposition génétique du patient ou antécédents d'effets indésirables graves du patient ou dans sa famille ;
    12. Evidence clinique d’une dépression respiratoire ;
    13. Evidence clinique d’une instabilité cardiovasculaire ;
    14. Atteinte rénale ou hépatique cliniquement significative, selon l’investigateur, pré-existante ou connue ;
    15. Présence de toute autre condition clinique qui peut, selon l'avis de l'investigateur, avoir un impact sur la capacité du patient à participer à l'étude ou sur les résultats de l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief (score ≤ 30 on the VAS).
    Le critère principal d'évaluation est le délai de soulagement de la douleur défini par la durée entre le début du traitement à l’étude (T0) et le soulagement de la douleur (score ≤ 30 sur l’EVA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes
    30 minutes
    E.5.2Secondary end point(s)
    In relation with the main objective:
    • Duration between the start of study treatment (T0) and pain relief reported by the patient.
    • Absolute Pain Intensity Difference (PID) measured using the VAS at 5, 10, 15, 20 and 30 min after T0. PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study.
    • Relative Pain Intensity Difference measured using the VAS at 5, 10, 15, 20 and 30 min after T0. Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0.
    • Pain relief defined by pain intensity < 40 mm on the VAS scale at 5, 10, 15, 20 and 30 min after T0,
    • Response defined by pain reduction of 20 mm on the VAS at 5, 10, 15, 20 and 30 min after T0
    • Response defined by pain reduction of 30% mm on the VAS at 5, 10, 15, 20 and 30 min after T0
    • Summed Pain Intensity Difference (SPID) for 30 minutes. SPID will be calculated by using the pain intensity difference (PID) at each of these assessment times provided in the study. SPID is the sum of the PID at each study assessment time, weighted by using the time elapsed since the previous assessment, and approaches the area under the curve for the PID over time. Relative to the VAS score, the SPID measurement has the advantage of considering individual differences at the level of initial pain intensity (baseline) as well as time.
    • % SPID33: SPID is usually described as a percentage of the maximum possible SPID (%SPID). The maximum possible SPID value is the value that would be obtained if the patient was pain free (VAS = 0) for the entire study period. The proportion of patients attaining an SPID of at least 33% will be calculated; this will be considered as corresponding to the responder rate. A % SPID of 33% was previously established as being a clinically significant measurement in pain results (Farrar JT, 2001).
    • Quantity of opioids received (in milligrams of morphine).

    In relation with the secondary objectives:
    • Description of the SoC and concomitant analgesic treatments from the World Health Organisation (http://www.who.int/cancer/palliative/painladder/en/): Type of drug, doses, administration periods, and treatment duration.
    • Sedation score (Ramsay scale)
    • Patient satisfaction score (Likert 0-5 scale)
    • Physician satisfaction scale (Likert 0-5 scale)
    • Nurse satisfaction scale (Likert 0-5 scale)
    • Length of stay (LOS) in emergency.
    • Assess the time until medical decision to discharge.

    Safety endpoints:
    • Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment
    • Variations of the vital signs (blood pressure, heart rate and respiration, oxygen saturation) in 30 minutes.
    • Incidence of tachycardia (heart rate > 100 beats/min), hypotension (systolic blood pressure [sBP] < 100 mmHg), hypertension (sBP > 180 mm Hg or diastolic blood pressure [dBP] > 100 mm Hg) and respiratory depression (respiratory frequency < 12 respirations/min, oxygen saturation < 92% or need for additional oxygen)
    • Incidence of premature withdrawal of patients for safety or tolerability reasons
    En relation avec l’objectif principal :
    • Durée entre le début du traitement à l’étude (T0) et le soulagement de la douleur déclaré par le patient.
    • Différence absolue d'intensité de la douleur (Pain Intensity Difference, PID) mesurée à l'aide de l'EVA à 5, 10, 15, 20 et 30 min après T0. PID pour un temps d’évaluation donné est égal au score EVA à T0 moins le score EVA à chaque temps d’évaluation prévu dans l’étude.
    • Différence relative d'intensité de la douleur relative mesurée à l'aide de l’EVA à 5, 10, 15, 20 et 30 min après T0. La différence relative d'intensité de la douleur pour un temps d’évaluation est égale au score EVA à T0 moins le score EVA à chaque temps d’évaluation prévu dans l’étude divisé par le score EVA à T0.
    • Soulagement de la douleur défini par l’intensité de la douleur < 40 mm sur l’échelle EVA à 5, 10, 15, 20 et 30 min après T0,
    • Réponse définie par la réduction de la douleur de 20 mm sur l’EVA à 5, 10, 15, 20 et 30 min après T0
    • Réponse définie comme une diminution de la douleur de 30% sur l’EVA à 5, 10, 15, 20 et 30 min après T0
    • Différence moyenne d'intensité de la douleur (Summed Pain Intensity Difference, SPID) pendant 30 minutes. Le SPID sera calculé en utilisant la différence d'intensité de la douleur (PID) à chacun de ces temps d'évaluation prévu dans l’étude. SPID est la somme du PID à chacun des temps d’évaluation de l'étude, pondérée en utilisant le temps écoulé depuis l'évaluation préalable, et se rapproche de l’aire sous la courbe pour le PID dans le temps. Par rapport au score EVA, la mesure du SPID a l’avantage de considérer les différences individuelles au niveau de l'intensité de la douleur initiale (baseline) ainsi que du temps.
    • % SPID33 : le SPID est habituellement décrit comme un pourcentage du SPID maximum possible (% SPID). La valeur maximale possible du SPID est la valeur qui serait obtenue si le patient était sans douleur (EVA = 0) pour toute la période de l’étude. La proportion de patients atteignant un SPID d’au moins 33% sera calculé ; ce taux sera considéré comme correspondant au taux de répondeurs. Un %SPID de 33% a été précédemment établi comme étant une mesure cliniquement importante dans les résultats de la douleur (Farrar JT, 2001).
    • Quantité d'opioïdes reçus (en milligrammes de morphine).

    En relation avec les objectifs secondaires :
    • Description du SoC et des traitements antalgiques concomitants selon l'échelle de l'Organisation Mondiale de la Santé (http://www.who.int/cancer/palliative/painladder/en/) : type de médicament, doses, périodes d'administration, et durée du traitement.
    • Score de sédation (échelle Ramsay)
    • Score de satisfaction du patient (échelle Likert 0-5)
    • Score de satisfaction du médecin (échelle Likert 0-5)
    • Score de satisfaction de l’infirmière (échelle Likert 0-5)
    • Durée du séjour au sein du service des urgences (length of stay, LOS).
    • Temps écoulé jusqu’à la décision médicale de sortie.

    Critères de tolérance :
    • Incidence des événements indésirables (EI) non associés au traumatisme sous-jacent et survenus pendant le traitement
    • Variations des signes vitaux (pression sanguine, fréquence cardiaque et respiratoire, saturation en oxygène) dans les 30 minutes
    • Incidence de la tachycardie (fréquence cardiaque > 100 battements/min), hypotension (pression sanguine systolique [sBP] < 100 mm Hg), hypertension (sBP > 180 mm Hg ou pression sanguine diastolique [dBP] > 100 mm Hg) et dépression respiratoire (fréquence respiratoire < 12 respirations/min, saturation en oxygène < 92% ou besoin de supplémentation en oxygène)
    • Incidence de sortie prématurée des patients pour des raisons de sécurité ou de tolérance
    E.5.2.1Timepoint(s) of evaluation of this end point
    For secondary endpoints in relation with the main objective: 30 minutes
    For secondary endpoints in relation with the secondary objective: Day 1-day of medical decision to discharge
    For safety endpoints: Day 15
    Critères d'évaluation en relation avec l'objectif principal : 30 minutes
    Critères d'évaluation en relation avec les objectifs secondaires : Jour 1 - Jour de décision médicale de sortie
    Critères de tolérance : Jour 15
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    PV follow-up end date of the last participant in the trial (15 days after the last visit of the last person participating in the trial)
    Date de fin de suivi PV de la dernière personne participant à l’essai (15 jours après la dernière visite de la dernière personne participant à l’essai)
    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 months6
    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: 360
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state360
    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)
    A telephone interview will take place 14 (± 2) days after the first treatment administration to assess the medium-term safety of the product.
    Entretien téléphonique aura lieu 14 (± 2) jours après la première prise du traitement pour évaluer la tolérance à moyen terme du produit.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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