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    Summary
    EudraCT Number:2017-000320-10
    Sponsor's Protocol Code Number:DEX-06-05
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-02-21
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-000320-10
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Dose-Controlled, Multicenter Study Evaluating
    the Safety and Efficacy of Dexmedetomidine in Intubated and Mechanically Ventilated Pediatric Intensive
    Care Unit Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, Randomized, Double-Blind, Dose-Controlled, Multicenter Study Evaluating
    the Safety and Efficacy of Dexmedetomidine in Intubated and Mechanically Ventilated Pediatric Intensive
    Care Unit Subjects
    A.4.1Sponsor's protocol code numberDEX-06-05
    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 SponsorHospira Inc
    B.1.3.4CountryUnited States
    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 supportHospira Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospira Inc
    B.5.2Functional name of contact pointGlobal Clinical R&D and Medical Aff
    B.5.3 Address:
    B.5.3.1Street Address275 North Field Drive
    B.5.3.2Town/ cityLake Forrest, IL
    B.5.3.3Post code60045
    B.5.3.4CountryUnited States
    B.5.4Telephone number1243589238
    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 Precedex
    D.2.1.1.2Name of the Marketing Authorisation holderHospira Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namedexmedetomidine HCl
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    Initially intubated and mechanically ventilated pediatric subjects in ICU setting
    E.1.1.1Medical condition in easily understood language
    Initially intubated and mechanically ventilated pediatric subjects in ICU setting
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    to characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects, to evaluate the safety an efficacy of loading and maintenance infusions for sedation on initially intubated and mechanically ventilated pediatric intensive care unit subjects and to explore the exposure-response relationship between dose of DEX and clinical neasures of sedation and safety
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Initially intubated and mechanically ventilated pediatric subjects (≥1 month (birth age corrected for
    prematurity) to <17 years of age) in an intensive care setting. The means by which the subject
    was intubated could include nasotracheal, endotracheal or via tracheotomy. The subject must
    have been mechanically ventilated prior to and during the commencement of study drug.
    2. Anticipated to require a minimum of 6 hours of continuous intravenous (IV) sedation.
    3. American Association of Anesthesiologists (ASA) classification of 1, 2, 3, or 4.
    4. A UMSS score of 1, 2, 3, or 4 at the start of infusion of study drug.
    5. A dose had been established for this subject's age based upon Table 1.
    6. If female, subject was non-lactating and was either:
    a. Not of childbearing potential, defined as pre-menarche, or surgically sterile due to
    bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
    b. Of childbearing potential but was not pregnant at time of baseline.
    7. Subject's parent(s) or legally acceptable representative had/have voluntarily signed and dated the
    informed consent document approved by the Institutional Review Board (IRB). Assent was
    obtained where age-appropriate and according to state regulations.
    E.4Principal exclusion criteria
    Pediatric subjects with neurological conditions that prohibited an evaluation of sedation in the
    opinion of the Investigator (e.g., increased intracranial pressure or extensive brain surgery).
    2. The infusion pump minimal capacity could not accommodate the lowest possible maintenance
    infusion rate of study drug based on subject's weight.
    3. Subjects with second degree or third degree heart block unless subject had a pacemaker or
    pacing wires.
    4. Hypotension that persisted beyond a 15-minute period of re-assessment prior to starting study
    drug:12
    • Age 1 month to ≤6 months old: systolic BP (SBP) <60 mmHg
    • Age >6 months to <2 years old: SBP <70 mmHg
    • Age >2 to <12 years old: SBP <80 mmHg
    • Age >12 to <17 years old: SBP <90 mmHg
    5. Pre-existing bradycardia that persisted beyond a 15-minute period of re-assessment prior to
    starting study drug:
    • Age 1 month to <2 months old: HR <90 beats per minute (bpm)
    • Age ≥2 months to <12 months old: HR <80 bpm
    • Age ≥12 months to <2 years old: HR <70 bpm
    • Age ≥2 to <12 years old: HR <60 bpm
    Age ≥12 to <17 yrs old: HR <50 bpm
    6. Alanine aminotransferase (ALT/ serum glutamic-pyruvic transaminase [SGPT]):
    • 1 month to 12 months old: >165 units/liter (U/L)
    • >12 months to <17 years old: ≥100U/L
    Note: Subjects could be re-screened up to 6 hours prior to study drug infusion (not including
    subjects undergoing cardiac surgery with CPB).
    7. Subjects had a known allergy to DEX, MDZ, morphine, or fentanyl.
    8. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain
    control.Subjects with immobility from neuromuscular disease, paralysis from administration of
    neuromuscular blocking (NMB) agents, spinal cord injury above T5 or subjects with muscle
    E.5 End points
    E.5.1Primary end point(s)
    The percent of subjects that do not require rescue MDZ for
    sedation based on achieving and maintaining a target UMSS score of 1 to 3 while intubated
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuous infusion of DEX must be at least 6 hours
    E.5.2Secondary end point(s)
    Secondary endpoints included the absolute time and percentage of time on study drug that the subject
    is in a UMSS score range of 1 to 3 while intubated; absolute time and percentage of time on study drug
    that the subject was out of the target sedation range while intubated (UMSS score of 0 or 4); total amount
    of rescue medication required for sedation and analgesia; time to first dose of rescue medication for
    sedation and analgesia; and time to extubation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    until extubation
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dose controlled
    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
    different dosage of the investigational product
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 175
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 60
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 175
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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