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   44334   clinical trials with a EudraCT protocol, of which   7366   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

    Download PDF

    Clinical Trial Results:
    Drug test detection 24 hours after nasal administration of cocaine as a local vasoconstrictor prior to nasal intubation

    Summary
    EudraCT number
    		 2021-000709-26
    Trial protocol
    		 DK  
    Global end of trial date
    27 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2024
    First version publication date
    16 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    50510617
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05334056
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 3, Copenhagen, Denmark,
    Public contact
    Department of Anesthesiology, Rigshospitalet, Centre of Head and Orthopaedics, +45 35453474, anop-hoc.rigshospitalet@regionh.dk
    Scientific contact
    Department of Anesthesiology, Rigshospitalet, Centre of Head and Orthopaedics, +45 35453474, anop-hoc.rigshospitalet@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine in saliva or its main metabolite benzoylecgonine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa.
    Protection of trial subjects
    Covered by the Danish 'Patienterstatningen'
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Sep 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    69
    From 65 to 84 years
    9
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 80
    Number of subjects completed
    		 80

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cocaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    2 mL 4% cocaine solution

    Number of subjects in period 1
    		Cocaine
    Started
    80
    Completed
    80

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 80 80
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 30 (24 to 49) -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 41 41

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cocaine
    Reporting group description
    		 -

    Primary: Drug test detection of cocaine

    		 Close Top of page
    End point title
    		 Drug test detection of cocaine [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 hours after drug administration
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Observational study. Number and proportion with a positive test of cocaine >0.01 mg/kg in whole blood 24 h after administration (percentage; 95% CI): 2/75 (3%; 0.3%–9%)
    End point values
    		 Cocaine
    Number of subjects analysed
    75
    Units: Above cut-off of 0.01 mg/kg
        Above cut-off of 0.01 mg/kg
    2
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 GCP
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Cocaine
    Reporting group description
    		 -

    Serious adverse events
    		 Cocaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 80 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cocaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 80 (28.75%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    23 / 80 (28.75%)
         occurrences all number
    23

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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 May 08 07:40:28 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA