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    Summary
    EudraCT Number:2017-000407-24
    Sponsor's Protocol Code Number:DEX-11-01
    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 number2017-000407-24
    A.3Full title of the trial
    A Phase II, Randomized, Open-Label, Single Center, Pharmacokinetic and
    Pharmacodynamic Study of Dexmedetomidine in Pediatric Subjects Aged
    12 months through <24 months
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Randomized, Open-Label, Single Center, Pharmacokinetic and
    Pharmacodynamic Study of Dexmedetomidine in Pediatric Subjects Aged
    12 months through <24 months
    A.4.1Sponsor's protocol code numberDEX-11-01
    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 Af
    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 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 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
    intubated and mechanically ventilated pediatric subjects that require sedation in
    an intensive care setting for a minimum of 6 hours but not to exceed 24 hours.
    Subjects eligible for enrollment are 12 months to < 24 months of age
    E.1.1.1Medical condition in easily understood language
    intubated and mechanically ventilated pediatric subjects that require sedation in
    an intensive care setting for a minimum of 6 hours but not to exceed 24 hours.

    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 define the pharmacokinetic (PK) profile of dexmedetomidine (DEX) administered
    as an intravenous (IV) loading dose followed by a continuous IV infusion in pediatric
    subjects 12 months through <24 months of age.
    2. To define the pharmacodynamic (PD) profile of dexmedetomidine (DEX)
    administered as an intravenous (IV) loading dose followed by a continuous IV
    infusion in pediatric subjects 12 months through <24 months of age.
    E.2.2Secondary objectives of the trial
    To evaluate safety in subjects 12 months through <24 months of age
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is 12 months to < 24 months of age at screening.
    2. Subject is intubated and mechanically ventilated in an intensive care setting and is
    anticipated to require a minimum of 6 hours of continuous IV sedation.
    3. Subject has adequate renal function, defined as:
    • Serum creatinine ≤ 1.0 mg/dL
    4. The subject’s parent(s) or legal guardian(s) must voluntarily sign and date the
    informed consent document approved by the Institutional Review Board.
    E.4Principal exclusion criteria
    Pediatric subjects with neurological conditions that prohibit an evaluation of
    sedation such as:
    • Diminished consciousness from increased intracranial pressure
    • Extensive brain surgery (surgery requiring intracranial pressure monitor)
    • Diminished cognitive function per Principal Investigator (PI) discretion
    • Subjects with immobility from neuromuscular disease or continuous infusion
    of neuromuscular blocking agents.
    2. Subjects with second degree or third degree heart block unless subject has a
    permanent pacemaker or pacing wires are in situ.
    3. Subjects who have hepatic impairment as defined by a SGPT/ALT >90 U/L at the
    time of Screening.
    4. Subjects who have hypotension, based on repeat assessments within 15 minutes
    preceding the start of study drug, defined as:
    • SBP < 70 mmHg
    5. Pre-existing bradycardia based on repeated assessments within 15 minutes
    preceding the start of study drug, defined as:
    • HR < 70 bpm
    6. Subject who have acute thermal burns involving more than 15 percent total body
    surface area.
    7. Subjects who have a known allergy to dexmedetomidine, MDZ or fentanyl.
    8. Subject who has received dexmedetomidine within 24 hours prior to the start of
    study drug.
    9. Subjects with a life expectancy that is < 72 hours.
    10. Subjects that are expected to have hemodialysis (continuous hemofiltration),
    peritoneal dialysis or extracorporeal membrane oxygenation (ECMO) treatments
    within 48 hours prior to the start of study drug or during the duration of the study.
    11. Subjects who have been treated with α-2 agonists/antagonists within two weeks
    (see Appendix B).
    12. Subjects with a spinal cord injury above T5.
    13. Subjects who have received another investigational drug as part of an
    investigational drug study within the past 30 days.
    14. Subjects who, in the opinion of the investigator, may not be able to comply with
    the safety monitoring requirements of this clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    To define the pharmacokinetic (PK) profile of dexmedetomidine (DEX) administered as an
    intravenous (IV) loading dose followed by a continuous IV infusion in pediatric subjects 12 months
    through < 24 months of age.
    2. To define the pharmacodynamic (PD) profile of DEX administered as an IV loading dose followed
    by a continuous IV infusion in pediatric subjects 12 months through < 24 months of age
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each subject received a loading dose of DEX over 10 minutes followed by the appropriate continuous
    infusion maintenance dose of DEX for a minimum of 6 but not more than 24 hours (including the loading
    dose time).
    E.5.2Secondary end point(s)
    To evaluate the safety of DEX in subjects 12 months through < 24 months of age.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each subject received a loading dose of DEX over 10 minutes followed by the appropriate continuous
    infusion maintenance dose of DEX for a minimum of 6 but not more than 24 hours (including the loading
    dose time).
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic and Pharmacodynamic study Subjects Aged 12 months through < 24 months
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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 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
    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 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 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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