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    Summary
    EudraCT Number:2015-004587-11
    Sponsor's Protocol Code Number:KUKIDEX-1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-004587-11
    A.3Full title of the trial
    Safety, tolerability and sedative properties of single dose intranasal dexmedetomidine premedication in elderly subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is dexmedetomidine a safe medicine to calm elderly patients when they are waiting for an operation?
    A.3.2Name or abbreviated title of the trial where available
    KUKIDEX-1
    A.4.1Sponsor's protocol code numberKUKIDEX-1
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointDepartment of Anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1 postbus 30.001
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503616161
    B.5.6E-mailc.r.m.barends@umcg.nl
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdexmedetomidine
    D.3.9.1CAS number 145108-58-3
    D.3.9.3Other descriptive nameDEXMEDETOMIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20317
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anxiety, preoperative
    E.1.1.1Medical condition in easily understood language
    Fear and anxiety in the hours directly preceding a surgical procedure
    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 assess the safety and tolerability of single ascending intranasal bolus doses of dexmedetomidine in people aged over 65
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetic and pharmocodynamic profile of dexmedetomidine after intranasal administration in elderly subject.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Planned for a maxillofacial procedure under general anesthetic in the UMCG planned on one of the planned study days
    2. Completed and cleared through the pre-anesthetic screening as per the standard protocol
    3. Adult, men and women, over 65 years of age, inclusive.
    4. Body Mass Index (BMI) ≥ 17.5 and ≤ 30.5 kg/m2, inclusive, and a total body weight >50 kg, at screening and check-in.
    5. American Society of Anesthesiologists (ASA) Physical Status 1 or 2 as determined in the preprocedural anaesthesiological screening
    6. Obtain a score of I or II using the Modified Mallampati Scoring.
    7. Understand the study procedures in the informed consent form(s) (ICF(s)), and be willing and able to comply with the protocol.
    8. For inclusion in the beta blocked arm subjects only: taking beta blocking medication at home in any dose or prescription.
    E.4Principal exclusion criteria
    1. For inclusion into the non-beta blocked arm: taking any type of beta-receptor blocking medication
    2. Contraindications for the use of dexmedetomidine
    3. Known intolerance to dexmedetomidine
    4. History or presence of significant cardiovascular disease (ASA >2), or significant cardiovascular disease risk factors, significant coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome.)
    5. History or presence of significant (ASA >2) pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological (inclusive of any seizure disorder), or psychiatric disease.
    6. History of any illness or medication use that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
    7. Surgery within the past 90 days prior to dosing judged by the PI to be clinically relevant.
    8. History of febrile illness within 5 days prior to dosing.
    9. History or presence of alcoholism or drug abuse within the past 2 years.
    10. Hypersensitivity or idiosyncratic reaction to components of dexmedetomidine, placebo components, or to compounds related to the study medications.
    11. Single 12-lead ECG demonstrating QTcF interval >450 msec at screening
    E.5 End points
    E.5.1Primary end point(s)
    • Number of subjects per dose cohort experiencing hypotension (defined as: a decrease in systolic, diastolic or Mean Arterial bloodpressure of >30% from baseline bloodpressure) for more than 5 minutes
    • Number of subjects per dose cohort experiencing bradycardia (defined as: a heart rate below 40 beats per minute) for more than 1 minute with evidence of inadequate tissue perfusion (hypotension, dizziness, syncope)
    • Maximum change from baseline in heart rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    After inclusion of all subjects or when the safety stopping criteria have been met
    E.5.2Secondary end point(s)
    • Maximum change from baseline in systolic, diastolic or mean arterial bloodpressure in 2,5 to minute intervals
    • Time of peak plasma level of dexmedetomidine
    • Peak plasmalevel dexmedetomidine
    • Per cohort and compared to placebo and other dosage cohort:
    • Mean change in mOAA/S over time at 2,5-5 min intervals
    E.5.2.1Timepoint(s) of evaluation of this end point
    After inclusion of all subjects or when the safety stopping criteria have been met
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 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
    After treatment of all 48 planned subject or when the specified safety stopping criteria have been met
    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 months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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.4.1In the member state48
    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)
    Patients will undergo the normal planned surgery under general anesthesia. After the surgery they will be in the Post-Anesthetic Care Unit until fully recovered from anesthesia.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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