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    Summary
    EudraCT Number:2016-001567-37
    Sponsor's Protocol Code Number:KUKIDEX-2
    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:2016-07-20
    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 number2016-001567-37
    A.3Full title of the trial
    Efficacy of single dose intranasal dexmedetomidine for conscious sedation in dental practice in dentophobic uncooperative patients with intellectual disability.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of dexmedetomidine for conscious sedation during dental treatement of uncooperative patients with intellectual disability and fear of dentists.
    A.3.2Name or abbreviated title of the trial where available
    KUKIDEX-2
    A.4.1Sponsor's protocol code numberKUKIDEX-2
    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 Gronignen
    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 pointTrialcoordinator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.6E-mailr.spanjersberg@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.2.1.1.2Name of the Marketing Authorisation holderOrion Company
    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 injection
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    dentophobia
    intellectual disability
    E.1.1.1Medical condition in easily understood language
    Fear of dentist
    Intellectual disability
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 demonstrate non-inferiority of a single dose of intranasal dexmedetomidine for conscious sedation of patients with intellectual disability with dentophobia to treatment under general anesthesia
    E.2.2Secondary objectives of the trial
    To assess the ease of induction of general anesthesia in patients with intellectual disabilities and dentophobia after a single dose of intranasal dexmedetomidine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Intellectual Disability of DSM-V classes Mild to Profound
    2. Documented failure to tolerate the indicated dental treatment with non-pharmacological support.
    3. Indication for dental treatment under general anesthesia because of 1 and 2.
    4. Completed and cleared through the pre-anesthetic screening as per the standard protocol of the UMCGs department of anesthesiology
    5. Adult, men and women, 18-55 years of age, inclusive.
    6. Body Mass Index (BMI) ≥ 17.5 and ≤ 35 kg/m2, inclusive, and a total body weight >50 kg, at screening and check-in.
    7. American Society of Anesthesiologists (ASA) Physical Status 1-3
    8. Able to understand the study procedures as described in the patient information sheet, willing and able to comply with the protocol, and to provide written informed consent OR in the case of legal incapability: a guardian understanding the study procedures as described in the patient information sheet, provides written informed consent.
    E.4Principal exclusion criteria
    1. Contraindications for the use of dexmedetomidine
    2. Known intolerance to dexmedetomidine
    3. History or presence of significant cardiovascular disease (ASA >3), or significant cardiovascular disease risk factors, significant coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome.)
    4. History or presence of significant (ASA >3) pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, disease.
    5. 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.
    6. Difficulty in airway management anticipated by the attending anesthesiologist .
    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, , or to compounds related to the study medications.
    11. Patients refusal or, in case of legal incapability:
    12. Guardians refusal
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of patients in whom dental treatment under procedural sedation with intranasal dexmedetomidine can be finished and is not terminated because of inadequate sedation.
    • Proportion of patients in whom dental treatment under general anesthesia can be finished and is not terminated because of inadequate sedation.
    • mRASS-score at specified dental treatment events after dexmedetomidine treatment compared to agitation score descriptor from the non-pharmacological Trial-of-Treatment
    • mRASS-score at specified events during induction for general anesthesia compared to agitation score descriptor from the non-pharmacological Trial-of-Treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of dental treatment until comlpetion of dental treatment or until induction of general anesthesia
    E.5.2Secondary end point(s)
    • Type of dental treatment events tolerated after dexmedetomidine treatment compared to type of dental treatment events tolerated without pharmacological support in the dental policlinic “Bijzondere Tandheelkunde”.
    • Progress made in dental treatment as compared to earlier Trial-of-Treatment without pharmacological support
    E.5.2.1Timepoint(s) of evaluation of this end point
    From start of dental treatment until comlpetion of dental treatment or until induction of general anesthesia
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Standard treatment under general anesthesia after induction as guided by institutional standard
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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) Yes
    F.1.2.1Number of subjects for this age range: 30
    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 No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Many subjects will be legally incapable on account of their intellectual disability.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    After participation in the trial subject and their guardians will be able to choose conscious sedation treatment in the future for further dental care. This treatment can still be carried out by the attending anesthesiologist
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-24
    P. End of Trial
    P.End of Trial StatusOngoing
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