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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    A randomised study of 5 and 10 days treatment with phenoxymethyl penicillin against streptococcal pharyngotonsillitis.

    Summary
    EudraCT number
    		 2015-001752-30
    Trial protocol
    		 SE  
    Global end of trial date
    15 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Aug 2019
    First version publication date
    31 Aug 2019
    Other versions
    Summary report(s)
    		 clinical study report
    code book
    full data set

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FoHM/Tonsillit2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02712307
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Public health Agency of Sweden
    Sponsor organisation address
    Nobels väg 18, Solna, Sweden, 171 82
    Public contact
    Antibiotics and Infection Control, Public Health Agency of Sweden, 46 102052000, charlotta.edlund@folkhalsomyndigheten.se
    Scientific contact
    Antibiotics and Infection Control, Public Health Agency of Sweden, 46 102052000, charlotta.edlund@folkhalsomyndigheten.se
    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
    25 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin in adults, adolecsents and children with streoptococcal tonsillitis.
    Protection of trial subjects
    None specific.
    Background therapy
    		 No medication with immunomodulating treatment corresponding to ≥15 mg prednisolone at inclussion. No treatment with antibiotics for pharyngotonsillitis in the last month (relapse), or any antibiotic treatment during the last 72 h before inclusion.
    Evidence for comparator
    		 It is the recommended dose regimen to patients with pharyngotonsillitis caused by GAS in Sweden.
    Actual start date of recruitment
    11 Sep 2015
    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
    Sweden: 422
    Worldwide total number of subjects
    422
    EEA total number of subjects
    422
    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)
    72
    Adolescents (12-17 years)
    33
    Adults (18-64 years)
    314
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Open randomised study. Patients were recruited from 17 PHCC in Sweden, from September 2015 to February 2018.

    Pre-assignment
    Screening details
    		 Patient aged 6 years or older with confirmed pharyngotonsillitis caused by Streptococcus Group A. Signed informed consent form.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5 days treatment
    Arm description
    		 Penicillin V 800 mg x 4 for 5 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Phenoxymethylpenicillin
    Investigational medicinal product code
    Other name
    Penicillin V
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg x 4 for 5 days

    Arm title
    		 10 days treatment
    Arm description
    		 Penicillin V 1000 mg x 3 for 10 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Phenoxymethylpenicillin
    Investigational medicinal product code
    Other name
    Penicillin V
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg x 3 for 10 days

    Number of subjects in period 1
    		5 days treatment 10 days treatment
    Started
    212
    210
    Completed
    212
    210

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    5 days treatment
    Reporting group description
    		 Penicillin V 800 mg x 4 for 5 days

    Reporting group title
    10 days treatment
    Reporting group description
    		 Penicillin V 1000 mg x 3 for 10 days

    Reporting group values
    		 5 days treatment 10 days treatment Total
    Number of subjects
    		 212 210 422
    Age categorical
    age
    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)
    		 41 31 72
        Adolescents (12-17 years)
    		 14 19 33
        Adults (18-64 years)
    		 155 159 314
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 138 132 270
        Male
    		 74 78 152
    Subject analysis sets

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    No violations to the study protocol

    Subject analysis set title
    MITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Had at least one dose of study drug

    Subject analysis sets values
    		 Per protocol population MITT
    Number of subjects
    397
    422
    Age categorical
    age
    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)
    72
        Adolescents (12-17 years)
    33
        Adults (18-64 years)
    314
        From 65-84 years
    3
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    138
        Male
    74

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    5 days treatment
    Reporting group description
    		 Penicillin V 800 mg x 4 for 5 days

    Reporting group title
    10 days treatment
    Reporting group description
    		 Penicillin V 1000 mg x 3 for 10 days

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    No violations to the study protocol

    Subject analysis set title
    MITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Had at least one dose of study drug

    Primary: Clinical cure at TOC

    		 Close Top of page
    End point title
    		 Clinical cure at TOC
    End point description
    End point type
    Primary
    End point timeframe
    5-7 Days after last dose of study drug
    End point values
    		 5 days treatment 10 days treatment Per protocol population MITT
    Number of subjects analysed
    212
    210
    397
    422
    Units: no of paients with clinical cure at TOC
    190
    197
    363
    387
    Statistical analysis title
    		 primary endpoint
    Statistical analysis description
    Categorical variables were presented as numbers (n) and percentages (%) and tested with Fisher´s exact test.
    Comparison groups
    5 days treatment v 10 days treatment
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 2.2
    Notes
    [1] - The primary efficacy variable, clinical cure, was presented with n (%), and the risk difference between the two treatment arms was presented with an approximate two-sided 95% confidence interval (CI). The analysis for the primary endpoint was performed on the PP population, supplemented by the MITT population. The non-inferiority margin of 10%.

    Secondary: bacteriological eradication at TOC

    		 Close Top of page
    End point title
    		 bacteriological eradication at TOC
    End point description
    End point type
    Secondary
    End point timeframe
    5 - 7 Days after last dose of study drug
    End point values
    		 5 days treatment 10 days treatment
    Number of subjects analysed
    194
    182
    Units: no of paients with bacteriologica at TOC
        bacteriological eradication
    156
    165
    Statistical analysis title
    		 secondary endpoint, bacteriological eradication
    Comparison groups
    5 days treatment v 10 days treatment
    Number of subjects included in analysis
    376
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 -2.7

    Secondary: relapse within one month

    		 Close Top of page
    End point title
    		 relapse within one month
    End point description
    End point type
    Secondary
    End point timeframe
    1 month after inclusion
    End point values
    		 5 days treatment 10 days treatment
    Number of subjects analysed
    179
    180
    Units: no of pations with relapse
        relapse
    8
    7
    No statistical analyses for this end point

    Secondary: complications within 3 months

    		 Close Top of page
    End point title
    		 complications within 3 months
    End point description
    End point type
    Secondary
    End point timeframe
    within 3 months after inclusion
    End point values
    		 5 days treatment 10 days treatment
    Number of subjects analysed
    198
    189
    Units: no of pations with complications within
        complication
    0
    4
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to three months after inclusion
    Adverse event reporting additional description
    Reported to doctor
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    MITT
    Reporting group description
    		 All patients who received at least one dose of study drug

    Serious adverse events
    		 MITT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 422 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 MITT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    219 / 422 (51.90%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    78 / 422 (18.48%)
         occurrences all number
    78
    Nausea
         subjects affected / exposed
    68 / 422 (16.11%)
         occurrences all number
    68
    Vomiting
         subjects affected / exposed
    8 / 422 (1.90%)
         occurrences all number
    8
    Abdominal pain
         subjects affected / exposed
    15 / 422 (3.55%)
         occurrences all number
    15
    Reproductive system and breast disorders
    Vaginal disorder
         subjects affected / exposed
    36 / 422 (8.53%)
         occurrences all number
    36
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    14 / 422 (3.32%)
         occurrences all number
    14

    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-Fri Apr 26 21:22:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA