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    Summary
    EudraCT Number:2014-005170-11
    Sponsor's Protocol Code Number:UCLDexAlf1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-24
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-005170-11
    A.3Full title of the trial
    Can we get conscious sedation in optimal safety conditions in an emergency department, by combining dexmedetomidine with alfentanil?
    Peut-on obtenir une sédation consciente, dans des conditions optimales, avec la dexmédétomidine en association avec l’alfentanil en salle d’urgence ?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can we get conscious sedation in optimal safety conditions in an emergency department, by combining dexmedetomidine with alfentanil?
    Peut-on obtenir une sédation consciente, dans des conditions optimales, avec la dexmédétomidine en association avec l’alfentanil en salle d’urgence ?
    A.4.1Sponsor's protocol code numberUCLDexAlf1
    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 SponsorCliniques universitaires Saint Luc
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOrion Pharma
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques universitaires Saint-Luc
    B.5.2Functional name of contact pointCUSL
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Hippocrate 10
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227648080
    B.5.5Fax number+3227641620
    B.5.6E-mailgregoirecharles1@gmail.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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameDexdor
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    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 Rapifen
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameRapifen
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room.
    E.1.1.1Medical condition in easily understood language
    Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to determine if combinaison of dexmédétomidine and alfentanil allows a level of conscious sedation within maximum security conditions in an emergency department.
    E.2.2Secondary objectives of the trial
    1. Check the relation between the patient's level of anxiety and the drugs (dexmédétomidine and l’alfentanil) quality of response
    2.Determine the requested total dose of dexmédétomidine to obtain a level of sedation corresponding to the Ramsey score 2-3
    3. Determine the requested time in minutes to reach the Ramsey score 2-3
    4.Determine the requested total dose of alfentanil to reach a good level of analgesia
    5.Observe the evolution of the pain score durring the procedure. It will be evaluated before and after the procedure with the numerical scale.
    6.Observe the evolution of the patient's anxiety before and after the treatment
    7. Compared the results with the « Assessment of Alertness/Sedation (OAA/S) scale » and those obtained by the Ramsay score assessment as well as to the modification of the bispectral index during the sedation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:
    • Insertion of a chest drain
    • Abscess incision and drainage
    • Electrical cardio version
    • Closed reduction of a dislocated joint
    E.4Principal exclusion criteria
    -Patients refusing to participate in the study (refusal to sign the consent form)
    -Patients refusing sedation
    -Patients unable to participate in the study (consent is impossible to obtain)
    -Pregnant women
    -Patients with poor respiratory status determined by :
    Respiratory rate > 30 / min
    Oxygen saturation <90%
    - Patients with unfavorable hemodynamic status determined by :
    A heart rate > 120 / min
    A heart rate < 45 / min
    Systolic blood pressure ≥ 180 mmHg or ≤100mmHg
    Diastolic blood pressure ≥ 110mmHg

    - Patients with contraindication to the use of dexmedetomidine :
    Advanced heart block (level 2 or 3) unless pacemaker
    Acute cerebrovascular disease
    E.5 End points
    E.5.1Primary end point(s)
    1. Can we obtain an adequate level of sedation with dexmedetomidine and alfentanyl in an emergency department?
    The Ramsay score scale will evaluate the sedation level
    The objective is to reach a score of 2 or 3 on the Ramsay score scale

    2. Can we do a procedural sedation with dexmedetomidine in optimal safety conditions in an emergency department?
    The optimal safety conditions are determined by:
    1. A stable blood pressure
    2. A stable heart rhythm
    3. No respiratory depression
    4. Absence of hypoxia
    5. Absence of vomiting
    E.5.1.1Timepoint(s) of evaluation of this end point
    The monitoring of the cardiovascular functions, the respiratory status and the sedation level will be performed as follows:
    Continually: for heart rate, oxygen saturation and EtCO2
    Every 3 min : for blood pressure and respiratory frequency
    Every 5 min : for Ramsay sedation score , the OAAS and BIS
    The observation of the change of the « Pleth Variability Index »

    The level of anxiety and pain will be evaluated before and after the procedure.
    The level of pain will be evaluated by a numerical scale (EN).
    The level of anxiety of the patient will be assessed by quantification of anxiety on a VAS scale.
    E.5.2Secondary end point(s)
    1. Wich dose of dexmedetomidine is needed to obtain the adequate sedation?

    2. How long do we need to obtain adequate sedation?

    3. Which dose of alfentanil do we need to obtain the adequate analgesia?

    4. Evolution of patient’s pain will be assessed during the procedure. It will be evaluated before and after the procedure using the numerical scale

    5. Evolution of patient’s pain will be assessed before and after the treatment of the combination dexmedetomidine – alfentanil

    6. A comparison will be made between changes in the bispectral index (BIS) during sedation with the results obtained by the scale of sedation " Assessment of Alertness / Sedation (OAA / S) scale " and those obtained by the Ramsay score scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    The monitoring of the cardiovascular functions, the respiratory status and the sedation level will be performed as follows:
    Continually: for heart rate, oxygen saturation and EtCO2
    Every 3 min : for blood pressure and respiratory frequency
    Every 5 min : for Ramsay sedation score , the OAAS and BIS
    The observation of the change of the « Pleth Variability Index »

    The level of anxiety and pain will be evaluated before and after the procedure.
    The level of pain will be evaluated by a numerical scale (EN).
    The level of anxiety of the patient will be assessed by quantification of anxiety on a VAS scale.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    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 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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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 Decision2014-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
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