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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2020-000578-31
    Sponsor's Protocol Code Number:SED002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-06-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-000578-31
    A.3Full title of the trial
    A Randomised Active-controlled Study to Compare Efficacy and Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) to Intravenous Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Compare the Effect and Safety of Inhaled Isoflurane to Intravenous Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
    A.3.2Name or abbreviated title of the trial where available
    IsoCOMFORT study
    A.4.1Sponsor's protocol code numberSED002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/092/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSedana Medical AB
    B.1.3.4CountrySweden
    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 supportSedana Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSedana Medical AB
    B.5.2Functional name of contact pointclinical@sedanamedical.com
    B.5.3 Address:
    B.5.3.1Street AddressVendevägen 89
    B.5.3.2Town/ cityDanderyd
    B.5.3.3Post code182 32
    B.5.3.4CountrySweden
    B.5.6E-mailclinicalresearch@sedanamedical.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 ISOFLURANE 100% Inhalation vapour, liquid
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Critical Care Limited (previously: Piramal Healthcare 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.3.4Pharmaceutical 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 INNISOFLURANE
    D.3.9.1CAS number 26675-46-7
    D.3.9.4EV Substance CodeSUB08319MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Midazolam 1 mg/ml Solution for Injection/Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderhameln pharmaceuticals 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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDAZOLAM
    D.3.9.1CAS number 59467-70-8
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Midazolam 2 mg/ml Solution for Injection/Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderhameln pharmaceuticals 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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDAZOLAM
    D.3.9.1CAS number 59467-70-8
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old
    E.1.1.1Medical condition in easily understood language
    Sedation in patients that are 3 to 17 (Less than 18) Years Old and where breathing is assisted by a Machine.
    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 PT
    E.1.2Classification code 10039897
    E.1.2Term Sedation
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10049683
    E.1.2Term Monitored anesthesia care sedation
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10062825
    E.1.2Term Monitored anaesthesia care sedation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the percentage of time adequate sedation depth is maintained within the individually prescribed target range in absence of rescue sedation as assessed according to the COMFORT-B scale, in isoflurane vs midazolam treated paediatric patients for an expected minimum of 12 hours.
    E.2.2Secondary objectives of the trial
    Secondary objectives, efficacy
    • Compare the use of opiates, and the development of tolerance to the sedative regimen as measured by the change in dose of study drug, opiates and other analgesics, over time in isoflurane- vs midazolam-treated patients.
    • Compare the need for rescue sedatives and other sedatives in isoflurane- vs midazolam-treated patients.

    Secondary objectives, safety
    Please see protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Paediatric patients at least 3 years to 17 (less than 18, patients who will turn 18 years during the study [including follow-up] will not be included) years at the time of randomisation, admitted to an ICU/with planned ICU admission.
    2. Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
    3. Informed consent obtained from the patient, patient’s legal guardian(s) as required by local regulations. Where applicable, assent obtained from the patient to participate in the clinical study.
    4. Germany only: Women of childbearing potential who are sexually active: The patient does already use a highly effective contraception method or agrees to use a highlyeffective contraception method from signing the informed consent form (screening) until the operation / study treatment. According to Clinical Trials Facilitation Group (CTFG) recommendations, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    • intrauterine device
    • intrauterine hormone-releasing system (IUS)
    • bilateral tubal occlusion
    • vasectomised partner
    • sexual abstinence or absence of sexual relations with men
    E.4Principal exclusion criteria
    1. Ongoing seizures requiring acute treatment.
    2. Continuous sedation for more than 72 hours at time of randomisation.
    3. Less than 24 hours post cardiopulmonary resuscitation.
    4. Uncompensated circulatory shock.
    5. Known hypersensitivity to isoflurane or to other halogenated anaesthetics (such as
    halothane), benzodiazepines, non-investigational medicinal product(s) (analgesics, additional rescue sedatives that may be required during the study) or to any of their formulation ingredients.
    6. Known or suspected genetic susceptibility to malignant hyperthermia.
    7. Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.
    8. Patient with tidal volumes below 30 mL or above 800 mL.
    9. Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator e.g. due to (not limited to):
    Severe traumatic brain injury, intracranial pathology (tumour, haemorrhage, infections), with a profound effect on the level of consciousness, severe mental retardation, major congenital anomalies of the central nervous system, severe myasthenia gravis, spinal muscular atrophy, or other severe neurologic disease, ongoing neuromuscular blockade which precludes COMFORT-B scoring.
    10. Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP
    11. Patients with treatment-induced whole-body hypothermia.
    12. Patients with pheochromocytoma.
    13. Patients with prolonged QT interval or with significant risk for prolonged QT interval.
    14. Patient not expected to survive next 48 hours or not committed to full medical care.
    15. Female patients who are pregnant or breast-feeding.
    16. Previous participation in the study (a patient can only participate once).
    17. Known participation in any other clinical study that included drug treatment within three months of the first administration of the IMP.
    18. Any for the study relevant medical history, or ongoing clinically significant disease, disorder or laboratory result which, in the opinion of the Investigator, precludes participation in the study for medical or ethical reasons.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 hours for a minimum of 12 hours (up to 48 hours ± 6 hours).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint assessment will start 2 hours after initiating study sedative treatment (or in the case of ongoing sedation, 2 hours after terminating ongoing sedatives). The primary endpoint assessment will be collected either until the study treatment is replaced with the standard treatment (at 48± 6 hours from study treatment initiation) or when the wake-up for extubation is started, whichever comes first.
    E.5.2Secondary end point(s)
    Secondary endpoints, efficacy
    • Dose of opiates, study drugs and other analgesics required, from first blinded COMFORT-B assessment (at +2 hours) to end of study treatment period, given per 24 hours.
    • Mean dose of study drugs, opiates and other analgesics required, during the last 4 hours of study treatment, as compared to the first 4 hours of study treatment after first blinded COMFORT-B assessment.
    • Mean dose of rescue propofol (mg/kg/24 hours) and mean dose of rescue ketamine/es- ketamine (converted to ketamine-equivalents mg/kg/24 hours), and mean dose of α2- adrenergic agonists (mg/kg/24 hours) to maintain the COMFORT-B score in the individually prescribed range, in isoflurane- vs midazolam-treated children (time window: from 2 hours after initiating study sedative treatment to end of sedative treatment).
    • Number of doses of rescue sedation (propofol, ketamine, es-ketamine) given per 24 hours from first blinded COMFORT-B assessment (at +2 hours) to end of study treatment period.
    Secondary endpoints, safety
    • Time from end of study drug administration to extubation if study drug is terminated for extubation.
    • Proportion of observations with spontaneous breathing efforts during study treatment.
    • Need for additional inotropic/vasopressor agent and change in VIS score during study treatment period compared to baseline.
    • Presence of withdrawal symptoms as assessed using the SOS-PD scale in patients exposed to more than a total of 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first.
    • Presence of delirium as assessed using the SOS-PD scale in patients admitted to the ICU for at least 48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first.
    • Proportion of patients experiencing psychomotor dysfunction or neurological symptoms during sedation and/or in the 48 hours after discontinuation of isoflurane or midazolam treatment, in relation to duration of exposure to isoflurane or midazolam,
    and to cumulative midazolam mg/kg or isoflurane exposure (MAC hours).
    • 30 days/hospital mortality.
    • Ventilator-free days at 30 days from start of study treatment period.
    • Time in intensive care unit/hospital at day 30 from start of study treatment period.
    • Days alive and not in the ICU at day 30 from start of study treatment period.
    • Proportion of patients with common as well as sedation-related adverse events, and frequencies of these adverse events from start of study treatment to end of 48-hour post
    study treatment monitoring.
    • Frequency and intensity of adverse events from start of study treatment to day 30.
    • Changes in vital signs, blood gases, body temperature and urinary output from baseline
    to end of study treatment.
    • Changes in clinical chemistry and haematology parameters from baseline up to the 48-
    hour post-study treatment monitoring.
    E.5.2.1Timepoint(s) of evaluation of this end point
    per protocol
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Assessor blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Last Patient Last Visit
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 160
    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: 140
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Unconscious patients at the time of inclusion
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-10
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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