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   43874   clinical trials with a EudraCT protocol, of which   7293   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:
    Placebo-controlled double-blind trial investigating the efficacy and tolerability of Posterisan® akut with lidocaine 60 mg/suppository in abatement of complaints associated with hemorrhoids

    Summary
    EudraCT number
    		 2012-002083-27
    Trial protocol
    		 DE  
    Global end of trial date
    27 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2016
    First version publication date
    05 Aug 2015
    Other versions
    Summary report(s)
    		 Synopsis KAD 169

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    KAD169
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Kade Pharmazeutische Fabrik GmbH
    Sponsor organisation address
    Rigistraße 2, Berlin, Germany, 12277
    Public contact
    Medical department, Dr. Kade Pharmazeutische Fabrik GmbH, 0049 3072082330, medizin@kade.de
    Scientific contact
    Medical department, Dr. Kade Pharmazeutische Fabrik GmbH, 0049 3072082330, medizin@kade.de
    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
    27 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Proof of superior efficacy of Posterisan® akut mit Lidocain 60 mg/Zäpfchen compared with placebo (vehicle without active substance) in the relief of symptoms associated with hemorrhoids
    Protection of trial subjects
    No specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2012
    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
    Germany: 203
    Worldwide total number of subjects
    203
    EEA total number of subjects
    203
    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)
    149
    From 65 to 84 years
    52
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited at study centers in Germany from November 2012 to August 2013.

    Pre-assignment
    Screening details
    		 Screening due to the inclusion and exclusion criteria, no special information

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject
    Blinding implementation details
    identical packaging and labelling of the two compounds

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Posterisan akut
    Arm description
    		 Treatment with lidocaine containing suppositories for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posterisan® akut mit Lidocain 60mg/ Zäpfchen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    2-3 times per day (single dose: 60 mg lidocaine) for a total treatment duration of 3 days

    Arm title
    		 Placebo
    Arm description
    		 Treatment with Placebo suppositories for 3 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    2-3 times per day (single dose: 60 mg lidocaine) for a total treatment duration of 3 days.

    Number of subjects in period 1
    		Posterisan akut Placebo
    Started
    102
    101
    Completed
    102
    101

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Posterisan akut
    Reporting group description
    		 Treatment with lidocaine containing suppositories for 3 days

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with Placebo suppositories for 3 days

    Reporting group values
    		 Posterisan akut Placebo Total
    Number of subjects
    		 102 101 203
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 78 69 147
        From 65-84 years
    		 24 30 54
        85 years and over
    		 0 2 2
    Gender categorical
    Units: Subjects
        Female
    		 49 57 106
        Male
    		 53 44 97
    Most bothersome symptom
    Most bothersome symptom (ie pain, burning or itching) is defined as the most annoying haemorrhoidal symptom at Baseline.
    Units: mmVAS
        arithmetic mean (standard deviation)
    		 77.6 ( 9.6 ) 78.9 ( 9.6 ) -
    Subject analysis sets

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Any subject who applied the trial medication at least once.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All ITT subjects who have concluded the trial in conformance with the trial protocol (i. e. without major protocol violation).

    Subject analysis sets values
    		 ITT population PP population
    Number of subjects
    203
    173
    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)
    147
    146
        From 65-84 years
    54
    25
        85 years and over
    2
    2
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    106
    89
        Male
    97
    84
    Most bothersome symptom
    Most bothersome symptom (ie pain, burning or itching) is defined as the most annoying haemorrhoidal symptom at Baseline.
    Units: mmVAS
        arithmetic mean (standard deviation)
    78.2 ( 9.6 )
    78.8 ( 9.4 )

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Posterisan akut
    Reporting group description
    		 Treatment with lidocaine containing suppositories for 3 days

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with Placebo suppositories for 3 days

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Any subject who applied the trial medication at least once.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All ITT subjects who have concluded the trial in conformance with the trial protocol (i. e. without major protocol violation).

    Primary: Improvement from Baseline in the most bothersome symptom at Day 3

    		 Close Top of page
    End point title
    		 Improvement from Baseline in the most bothersome symptom at Day 3 [1]
    End point description
    Improvement from Baseline in the most bothersome symptom at the day of treatment completion (Day 3)
    End point type
    Primary
    End point timeframe
    3 days
    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: See attached synopsis
    End point values
    		 Posterisan akut Placebo ITT population PP population
    Number of subjects analysed
    102
    101
    203
    173
    Units: mmVAS
        arithmetic mean (standard deviation)
    33.3 ( 24.1 )
    32.9 ( 25.7 )
    33.1 ( 24.9 )
    33.7 ( 23.8 )
    No statistical analyses for this end point

    Secondary: Improvement from Baseline in MBS at treatment Day 1

    		 Close Top of page
    End point title
    		 Improvement from Baseline in MBS at treatment Day 1
    End point description
    Improvement from Baseline in MBS at treatment Days 1 and 2
    End point type
    Secondary
    End point timeframe
    1 day
    End point values
    		 Posterisan akut Placebo
    Number of subjects analysed
    102
    101
    Units: mmVAS
        arithmetic mean (standard deviation)
    17.8 ( 23.8 )
    16.8 ( 19.3 )
    No statistical analyses for this end point

    Secondary: Between-group comparison of MBS responder rates at Day 3

    		 Close Top of page
    End point title
    		 Between-group comparison of MBS responder rates at Day 3
    End point description
    Between-group comparison of MBS responder rates (response defined as an absolute value ≤30 mmVAS) at the day of treatment completion (Day 3).
    End point type
    Secondary
    End point timeframe
    3 days
    End point values
    		 Posterisan akut Placebo
    Number of subjects analysed
    102
    101
    Units: number subjects
    31
    28
    No statistical analyses for this end point

    Secondary: Improvement from Baseline in MBS at treatment Days 2

    		 Close Top of page
    End point title
    		 Improvement from Baseline in MBS at treatment Days 2
    End point description
    End point type
    Secondary
    End point timeframe
    2 days
    End point values
    		 Posterisan akut Placebo
    Number of subjects analysed
    102
    101
    Units: mmVAS
        arithmetic mean (standard deviation)
    25 ( 22.1 )
    25.4 ( 21.8 )
    No statistical analyses for this end point

    Secondary: Mean changes in burning from baseline to Day 4

    		 Close Top of page
    End point title
    		 Mean changes in burning from baseline to Day 4
    End point description
    End point type
    Secondary
    End point timeframe
    4 days
    End point values
    		 Posterisan akut Placebo
    Number of subjects analysed
    102
    101
    Units: mmVAS
        arithmetic mean (standard deviation)
    26.6 ( 28 )
    29.5 ( 26.2 )
    No statistical analyses for this end point

    Secondary: Mean changes in itching from baseline to Day 4

    		 Close Top of page
    End point title
    		 Mean changes in itching from baseline to Day 4
    End point description
    End point type
    Secondary
    End point timeframe
    4 days
    End point values
    		 Posterisan akut Placebo
    Number of subjects analysed
    102
    101
    Units: mmVAS
        arithmetic mean (standard deviation)
    32.4 ( 28.8 )
    34.8 ( 30.1 )
    No statistical analyses for this end point

    Post-hoc: Mean changes in pain from Baseline to Day 4

    		 Close Top of page
    End point title
    		 Mean changes in pain from Baseline to Day 4
    End point description
    Mean changes in pain from Baseline (Day 0) to final study assessment (Day 4)
    End point type
    Post-hoc
    End point timeframe
    4 days
    End point values
    		 Posterisan akut Placebo
    Number of subjects analysed
    102
    101
    Units: mmVAS
        arithmetic mean (standard deviation)
    19.9 ( 32.3 )
    21.5 ( 29.5 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to Day 4
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Posterisan akut
    Reporting group description
    		 Subjects who administered Posterisan akut

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who administered placebo

    Serious adverse events
    		 Posterisan akut Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Posterisan akut Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 102 (10.78%)
    10 / 101 (9.90%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1
    Dysgeusia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Anal fissure
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 101 (1.98%)
         occurrences all number
    4
    2
    Abdominal pain
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 101 (0.99%)
         occurrences all number
    2
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 102 (0.98%)
    3 / 101 (2.97%)
         occurrences all number
    1
    3
    Defaecation urgency
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    3 / 102 (2.94%)
    3 / 101 (2.97%)
         occurrences all number
    3
    3
    Flatulence
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    Rectal discharge
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2013
    Addition of study centers

    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 09 00:26:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA