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    Clinical Trial Results:
    Comparison of the efficacy of treatment of chronic periodontitis with scaling and root-planning alone or in combination with azithromycin - a prospective, double blind, randomised clinical trial

    Summary
    EudraCT number
    		 2015-004306-42
    Trial protocol
    		 SI  
    Global end of trial date
    06 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2021
    First version publication date
    06 Mar 2021
    Other versions
    Summary report(s)
    		 Article report
    Demographic data
    Healed sites
    Risk factors
    12 months outcomes
    Differences
    Raw data

    Trial information

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    Trial identification
    Sponsor protocol code
    2016-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Stomatološka klinika UKC, Ljubljana
    Sponsor organisation address
    Hrvatski trg 6, Ljubljana, Slovenia, 1000
    Public contact
    CLinical Trials INformations, Stomatološka klinika UKC, Ljubljana, 00386 15224889, rok.gaspersic@mf.uni-lj.si
    Scientific contact
    CLinical Trials INformations, Stomatološka klinika UKC, Ljubljana, 00386 15224889, rok.gaspersic@mf.uni-lj.si
    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
    06 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone
    Protection of trial subjects
    Regular check-up every 3 months.
    Background therapy
    		 Scaling and root planing
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2016
    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
    Slovenia: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Finished Recruited between march 2016 and march 2018

    Pre-assignment
    Screening details
    		 732 screened 40 selected

    Period 1
    Period 1 title
    Complete dataset (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Identical appearance of active substance and placebo

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Azithromycin
    Arm description
    		 500 mg tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azibiot
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg every 24hrs 3 consecutive days

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one tablet every 24 hrs 3 consecutive days

    Number of subjects in period 1
    		Azithromycin Placebo
    Started
    20
    20
    Completed
    19
    19
    Not completed
    1
    1
         tetraplegia due to accident
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Azithromycin
    Reporting group description
    		 500 mg tablets

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Azithromycin Placebo Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44 ( 8 ) 45 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 12 14 26

    End points

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    End points reporting groups
    Reporting group title
    Azithromycin
    Reporting group description
    		 500 mg tablets

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Diseased sites

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    End point title
    		 Diseased sites
    End point description
    Number of sites with PPD > 4 mm and BOP
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Azithromycin Placebo
    Number of subjects analysed
    19
    19
    Units: Number
    4
    6
    Statistical analysis title
    		 Wilcoxon’s rank sum test
    Statistical analysis description
    Wilcoxon’s rank sum test
    Comparison groups
    Azithromycin v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Probing depth

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    End point title
    		 Probing depth
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Azithromycin Placebo
    Number of subjects analysed
    19
    19
    Units: mm
    median (inter-quartile range (Q1-Q3))
        12 months
    2.7 (2.2 to 3.3)
    2.7 (2.4 to 3.1)
    No statistical analyses for this end point

    Secondary: Clinical attachment loss

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    End point title
    		 Clinical attachment loss
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Azithromycin Placebo
    Number of subjects analysed
    19
    19
    Units: mm
    median (inter-quartile range (Q1-Q3))
        12 months
    3.6 (2.9 to 4.8)
    3.7 (2.7 to 4.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Adverse event reporting additional description
    Nausea, headache
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Azithromycin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Azithromycin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Azithromycin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

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    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
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    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.

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