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    Summary
    EudraCT Number:2017-000408-71
    Sponsor's Protocol Code Number:DEX-11-06
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-02-27
    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 number2017-000408-71
    A.3Full title of the trial
    A Phase II/Ill, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine in
    Preterm Subjects Ages 28 Weeks to < 36 Weeks Gestational Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II/Ill, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine in
    Preterm Subjects Ages 28 Weeks to < 36 Weeks Gestational Age
    A.4.1Sponsor's protocol code numberDEX-11-06
    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 pointGlobai Clinical R&D and Medical Aff
    B.5.3 Address:
    B.5.3.1Street Address275 Noerth 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 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 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 and solvent for solution for injection/infusion
    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
    Initially intubated and mechanically ventilated preterm
    subjects ... 28 weeks through < 36 weeks, gestational age, having a weight of > 1000 g, in an intensive
    care setting anticipated to require at least 6 hours of continuous intravenous sedation.
    E.1.1.1Medical condition in easily understood language
    Initially intubated and mechanically ventilated preterm
    subjects in an intensive
    care setting anticipated to require at least 6 hours of continuous intravenous sedation.
    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
    The primary objective of this study was to characterize the safety and efficacy of
    Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV
    infusion in preterm subjects, ages ?_ 28 weeks through < 36 weeks gestational age.
    E.2.2Secondary objectives of the trial
    Not applicaple
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting
    anticipated to require at least 6 hours of continuous IV sedation.
    2. Age: subjects had to be in the following age range at screening:
    Preterm subjects z 28 weeks through < 36 weeks, gestational age;
    Note: Gestational age (in weeks) was calculated as follows: the time elapsed between the first
    day of the last menstrual period and the day of enrollment. 14
    3. Weight: subject's weight at the time of enrollment had to be > 1000 g.
    4. Subject's parent(s) or legal guardian(s) had voluntarily signed and dated the informed consent
    document approved by the IRB/ IEC.
    E.4Principal exclusion criteria
    1. Neonate subjects with neurological conditions that prohibited an evaluation of sedation such as:o Diminished consciousness from increased intracranial pressure.
    O The presence of catastrophic brain injury or other severe mental disorders that would make
    responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
    O Subjects with immobility from neuromuscular disease or continuous infusion of
    neuromuscular blocking (NMB) agents.
    2. Subjects with second degree or third degree heart block unless subject has a pacemaker or
    pacing wires were in situ.
    Note: If subject's status-post Cardiopulmonary Bypass (CPB) was being managed without
    pacing wires in situ, the subject could not have been suspected to be in second degree or
    third degree heart block at the time of DEX administration.
    3. HR < 120 bpm prior to the initiation of DEX.
    4. Exposure to any investigational drug within 30 days prior to DEX administration.
    5. Previous exposure to DEX as part of an investigational study.
    6. In subjects that were ex-utero for less than 72 hours, a maternal history of poly-substance drug
    abuse, based upon the Investigator's clinical judgment.
    7. At the discretion of the Investigator, subjects in whom the risk of DEX treatment was expected to
    exceed its benefits.
    8. Subjects who had a known allergy or contraindication to fentanyl, morphine, MDZ, DEX, or other
    a-2 agonists.
    9. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain
    control.10. Screening Alanine Aminotransferase (ALT) levels > 115 UIL.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the study was the frequency of subjects requiring any use of rescue
    medication, midazolam (MDZ), for sedation during DEX infusion
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each subject received a 10- or 20- minute loading dose infusion of DEX followed
    by a continuous fixed maintenance dose infusion of DEX for at least 6 hours but not more than 24 hours.
    E.5.2Secondary end point(s)
    Incidence of rescue medication use (fentanyl or morphine) for analgesia during DEX infusion
    ° Amount of rescue medication (MDZ) for sedation during DEX infusion
    • Amount of rescue medication for analgesia during DEX infusion
    ° Change from baseline in vital signs (heart rate, blood pressure, mean arterial pressure), respiratorySafety:
    • the incidence of AEs
    ° Changes from baseline in vital signs
    ° Changes from screening in clinical laboratory tests
    ° Changes in input/output fluid balance
    0 Changes from baseline in ECG
    ° Use of rescue regimens to support vital signs
    ° Use of adjunct medications
    rate and oxygen saturation measures during DEX infusion
    0 Time spent with a total N-PASS score >3 during DEX infusion
    ° Time to extubation was explored in DEX-exposed subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each subject received a 10- or 20- minute loading dose infusion of DEX followed
    by a continuous fixed maintenance dose infusion of DEX for at least 6 hours but not more than 24 hours.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial1
    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 years0
    E.8.9.2In all countries concerned by the trial months2
    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: 6
    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: 6
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 6
    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
    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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