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   44237   clinical trials with a EudraCT protocol, of which   7338   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:
    Adjuvante Imiquimod Therapie zur Senkung der Rezidivrate nach operativer Therapie bei analen HPV-Läsionen

    Summary
    EudraCT number
    		 2017-000842-23
    Trial protocol
    		 AT  
    Global end of trial date
    29 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2021
    First version publication date
    27 Mar 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AdAM_2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Anichstraße 35, Innsbruck, Austria, 6020
    Public contact
    Dr. med. Sascha Czipin, Medical University Innsbruck, ++43 51250480823, mui-sponsor@i-med.ac.at
    Scientific contact
    Dr. med. Sascha Czipin, Medical University Innsbruck, ++43 51250480823, mui-sponsor@i-med.ac.at
    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
    29 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of the study is to evaluate the efficacy of combination therapy of surgical intervention and "adjuvant" topical Imiquimod therapy
    Protection of trial subjects
    Since the recruitment phase never started, no patients have been enrolled. Hence no protection of trial subjects has been necessary
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 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
    Austria: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 No patients were recruited for this trial. "99999" is a value for 0 participants

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Imiquimod – Aldara 5%-Creme
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imiquimod – Aldara 5%-Creme
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Subject would have been treated using the following scheme: Each crucible contains 12.5 mg Imiquimod in 250 mg Creme (5%). The cream should be administered 3 times per week over a period of 12 weeks before going to bed. The creme should be left on the skin for 6 to 10 hours and can be washed away with water on the next morning.

    Number of subjects in period 1
    		Imiquimod – Aldara 5%-Creme
    Started
    99999
    Completed
    99999

    Baseline characteristics

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

    Reporting group values
    		 Treatment period (overall period) Total
    Number of subjects
    		 99999 99999
    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)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Imiquimod – Aldara 5%-Creme
    Reporting group description
    		 -

    Primary: Effectiveness of the Combination therapy of surgical therapy and "adjuvant" topical imiquimod therapy

    		 Close Top of page
    End point title
    		 Effectiveness of the Combination therapy of surgical therapy and "adjuvant" topical imiquimod therapy [1]
    End point description
    End point type
    Primary
    End point timeframe
    N/A
    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: No subjects were included in this trial, therefore no statistical analysis was done.
    End point values
    		 Imiquimod – Aldara 5%-Creme
    Number of subjects analysed
    99999 [2]
    Units: N/A
    99999
    Notes
    [2] - "99999" is a value for 0 participants
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    01.07.2018 - 29.01.2021
    Adverse event reporting additional description
    No patients were included in this trial, therefore no AEs and SAEs were reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No subjects were included in this trial, therefore no AEs or SAEs were observed

    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.
    No subjects were enrolled in this trial. "99999" is a value for 0 participants, as it was not possible to fill in "0" for the number for included patients.
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA