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   43851   clinical trials with a EudraCT protocol, of which   7283   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:
    Effect of codeine on pharyngeal and esophageal motility in healthy subjects: a double-blind, placebo-controlled, randomized, cross-over study

    Summary
    EudraCT number
    		 2017-002349-30
    Trial protocol
    		 BE  
    Global end of trial date
    30 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2021
    First version publication date
    04 Feb 2021
    Other versions
    Summary report(s)
    		 Article codeine study

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    cod2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03784105
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TARGID
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Prof Jan Tack, TARGID, KU Leuven, 32 16344775 , jan.tack@kuleuven.be
    Scientific contact
    Prof Jan Tack, TARGID, KU Leuven, 32 16344775 , jan.tack@kuleuven.be
    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
    28 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of codeine on pharyngeal and esophageal motility in healthy subjects
    Protection of trial subjects
    Local anesthesia was provided in the nose to minimalize pain and discomfort during the placement of the nasogastric measuring probe.
    Background therapy
    		 /
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2018
    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
    Belgium: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Healthy volunteers will be selected via a database that is available in the lab and via mouth to mouth recruitment.

    Pre-assignment
    Screening details
    		 Inclusion: 18-60 year old, written informed consent before any study procedure, go home without driving a vehicle, will not operate machines on the study day, not pregnant or breastfeeding. Exclusion: other significant diseases, upper GI symptoms or surgery, known side-effects to morphine/codeine, medication use (oral contraceptives allowed)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Codeine was inserted via a naso-gastric tube into the stomach to avoid recognition of the taste of codeine.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Codeine
    Arm description
    		 We will administer the codeine intra-gastrically as a syrup: Bronchodine® 10mg/5ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bronchodine® 10mg/5ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Intragastric use
    Dosage and administration details
    30 mL of Bronchodine® 10mg/5ml

    Arm title
    		 Placebo
    Arm description
    		 As placebo we will administer the same volume (30 ml) of a glucose syrup, also intra-gastrically.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sirupus Simplex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Intragastric use
    Dosage and administration details
    As placebo we will administer the same volume (30 ml) of a glucose syrup (Siripus Simplex), also intra-gastrically.

    Number of subjects in period 1
    		Codeine Placebo
    Started
    20
    19
    Completed
    19
    19
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.5 ( 0.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 5 5

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Codeine
    Reporting group description
    		 We will administer the codeine intra-gastrically as a syrup: Bronchodine® 10mg/5ml.

    Reporting group title
    Placebo
    Reporting group description
    		 As placebo we will administer the same volume (30 ml) of a glucose syrup, also intra-gastrically.

    Primary: Integrated relaxation pressure 4s

    		 Close Top of page
    End point title
    		 Integrated relaxation pressure 4s
    End point description
    End point type
    Primary
    End point timeframe
    comparison between two conditions
    End point values
    		 Codeine Placebo
    Number of subjects analysed
    19
    19
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    18 (15 to 21)
    10 (8 to 14)
    Statistical analysis title
    		 Mixed models primary endpoint
    Statistical analysis description
    Mixed models were constructed with the integrated relaxation pressure 4s as the dependent variable and and treatment condition (codeine or placebo) as within-subject independent, categorical variables.
    Comparison groups
    Codeine v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were reported for each patient from the start of visit 1 untill the end of visit 2.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Codeine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The occurence of non-serious adverse events was below 5%
    Serious adverse events
    		 Codeine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    biliary type pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Codeine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)

    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-Sat Apr 20 17:26:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA