Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-004264-19
    Sponsor's Protocol Code Number:NEODEX2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-23
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-004264-19
    A.3Full title of the trial
    Anesthesia with dexmedetomidine and fentanyl for neonatal surgery. A pilot study.
    Anestesi med dexmedetomidine och fentanyl för nyföddhetskirurgi. En pilotstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anesthesia with dexmedetomidine for surgery in newborn babies. Does it work?
    Anestesi med dexmedetomidine och fentanyl för nyföddhetskirurgi. En pilotstudie.
    A.3.2Name or abbreviated title of the trial where available
    DEX for neonatal anesthesia
    DEX för neonatal anestesi
    A.4.1Sponsor's protocol code numberNEODEX2
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN11031435
    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 SponsorUppsala County Council
    B.1.3.4CountrySweden
    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 supportUppsala County Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala University Hospital
    B.5.2Functional name of contact pointANIVA
    B.5.3 Address:
    B.5.3.1Street AddressSjukhusvägen 1
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46186110000
    B.5.6E-mailpeter.frykholm@akademiska.se
    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 Corporation
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Concentrate for solution for 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
    The state of anesthesia intraoperatively and pain postoperatively
    Anestesi och postoperativ smärta
    E.1.1.1Medical condition in easily understood language
    Anesthesia during surgery and pain after surgery
    Narkos under operation och smärta efter operation
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    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 feasibility of using dexmedetomidine as an alternative to sevoflurane together with high dose fentanyl for neonatal anesthesia
    Att evaluera om dexmedetomidin kan användas som alternativ till sevoflurane som anestesimedel tillsammans med högdos fentanyl vid nyföddhetskirurgi
    E.2.2Secondary objectives of the trial
    1. To evaluate the indicence of adverse events related to dexmedetomidine infusion in neonatal surgeyr.
    2. To evaluate if dexmedetomidine has opioid-sparing effects if continued after surgery in neonates.
    1. Att kartlägga incidensen biverkningar relaterade till dexmedomidin vid nyföddhetskirurgi.
    2. Att evaluera om dexmedetomidin har opioid-sparande effekter vid fortsatt infusion efter nyföddhetskirurgi
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Blood sampling for PK-PD analysis will be saved for later analysis.
    Blodprover för att analysera farmakokinetik och farmakodynamik sparas för senare analys.
    E.3Principal inclusion criteria
    1. Neonate admitted to the neonatal intensive care unit
    2. Neonate scheduled for abdominal or thoracic surgery requiring anesthesia
    3. Plan for delayed extubation in the neonatal intensive care unit with morphine as analgesia
    !. Spädbarn som vårdas på neonatalavdelning
    2. Planerad buk- eller thoraxkirurgi som kräver anestesi
    3. Planerad extubation efter fortsatt vård på neonatalavdelning med morfin som analgesi
    E.4Principal exclusion criteria
    1. Planned extubation in the operating room
    2. Hemodynamic instability requiring inotropes preoperatively
    3. Body weight < 2 kg
    4. Patient gestational age <37 weeks or > 44 weeks
    5. On-going treatment with alpha-2-agonist, or such treatment discontinued within 12 hours from the start of the protocol.
    1. Extubation direkt efter operation planerad
    2. Hemodynamisk instabilitet som kräver vasoaktivt stöd
    3. Vikt < 2 kg
    4. Ålder < 37 gestationsveckor, ålder > 44 gestationsveckor.
    5. Pågående behandling med alfa-2-agonist, eller sådan behandling som är avslutad inom 12 timmar före studiestart.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is completion of the anesthesia and surgery without the use of rescue anesthesia with sevoflurane or propofol and without the occurrence of serious adverse events.
    Slutförd anestesi med dexmedetomidin utan tillägg av annat sömnmedel som sevoflurane eller propofol och utan förekomst av allvarliga biverkningar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the anesthetic, at handover to the NICU team.
    Vid anestesiavslutning när patienten lämnas över till neonatalavdelningens personal.
    E.5.2Secondary end point(s)
    1. Incidence of adverse events:
    changes in blood pressure > 20% from baseline, incidence of heart rate < 100 bpm.
    2. Postoperative opioid consumption during postoperative day 0, 1 and 2, respectively, compared with matched historical controls.
    1. Förekomst av blodtrycksförändringar mer än 20% från baseline. Förekomst av bradykardi (puls<100)
    2. Postoperativ opioidanvändning dag 0, 1, och 2, jämfört med matchade historiska kontroller.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours after handover to NICU team
    48 timmar efter anestesiavslutning och överlämnande till neonatalavdelningen
    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 Yes
    E.6.6Pharmacokinetic Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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
    LVLS
    Studien avslutas när 12 forskningspersoner inkluderats och genomfört protokollet
    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 months0
    E.8.9.1In the Member State concerned 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: 12
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 12
    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) 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 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
    Neonates in which major surgery (e g laparotomy or thoracotomy) is indicated. Parents will be asked for informed consent
    Nyfödda spädbarn som behöver opereras t ex med laparotomi eller thorakotomi. Informerat samtycke inhämtas från föräldrar.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    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
    Ingen
    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 Decision2017-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 02:07:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA