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    Clinical Trial Results:
    Local, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen And Amoxicillin in Pediatric Patients

    Summary
    EudraCT number
    		 2014-004002-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jun 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    28 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KETOP_L_03102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00799838
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi-aventis Farmacêutica Ltda
    Sponsor organisation address
    Avenida Major Sylvio de Magalhães Padilha, 5.200. Edifício Atlanta - Jd. Morumbi , São Paulo, Brazil, 05693-000
    Public contact
    Trial Transparency Team, Sanofi-aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi-aventis recherche & développement, Contact-US@sanofi.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the reduction of inflammatory signs and symptoms (hyperemia, edema and pain) after 24 hours of treatment with ketoprofen when associated with amoxicillin.
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of paediatric subjects. The subject (s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. Consent form in appropriate language was explained and provided to parent(s)/guardian(s). Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2008
    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
    Brazil: 106
    Worldwide total number of subjects
    106
    EEA total number of subjects
    0
    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)
    106
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 6 centres in Brazil. A total of 111 subjects were screened between 17 Nov 2008 and 12 June 2013.

    Pre-assignment
    Screening details
    		 Out of 111 screened subjects, 5 subjects were screen failures and 106 subjects were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ketoprofen + Amoxicillin
    Arm description
    		 Ketoprofen drops for 3 days along with Amoxicillin for 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketoprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old, administered three times a day (TID).

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    20-40 mg/Kg/day, administered TID.

    Arm title
    		 Placebo + Amoxicillin
    Arm description
    		 Placebo (ketoprofen) drops for 3 days along with Amoxicillin for 10 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    20-40 mg/Kg/day, administered TID.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old, administered TID.

    Number of subjects in period 1
    		Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Started
    51
    55
    Treated
    51
    55
    Completed
    48
    52
    Not completed
    3
    3
         Consent withdrawal
    1
    -
         Adverse event leading to the study withdrawal
    2
    2
         Not attended Visit 2 at scheduled date
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ketoprofen + Amoxicillin
    Reporting group description
    		 Ketoprofen drops for 3 days along with Amoxicillin for 10 days.

    Reporting group title
    Placebo + Amoxicillin
    Reporting group description
    		 Placebo (ketoprofen) drops for 3 days along with Amoxicillin for 10 days.

    Reporting group values
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin Total
    Number of subjects
    		 51 55 106
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.9 ± 2.3 7.5 ± 2.2 -
    Gender categorical
    Units: Subjects
        Female
    		 27 30 57
        Male
    		 24 25 49

    End points

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    End points reporting groups
    Reporting group title
    Ketoprofen + Amoxicillin
    Reporting group description
    		 Ketoprofen drops for 3 days along with Amoxicillin for 10 days.

    Reporting group title
    Placebo + Amoxicillin
    Reporting group description
    		 Placebo (ketoprofen) drops for 3 days along with Amoxicillin for 10 days.

    Primary: Number of Subjects with Reduction of Inflammatory Signs and Symptoms After 24 Hours of Treatment

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    End point title
    		 Number of Subjects with Reduction of Inflammatory Signs and Symptoms After 24 Hours of Treatment [1]
    End point description
    Inflammatory signs and symptoms included hyperemia, edema and pain. Reduction was considered when there was an improvement in at least two of the three signs / symptoms evaluated. Analysis was performed on modified intent-to-treat (mITT) population defined as all randomized and treated subjects with available information for primary efficacy evaluation. Two subjects from "Ketoprofen + Amoxicillin" group did not have Visit 1 assessment and were excluded.
    End point type
    Primary
    End point timeframe
    24 hours
    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: As the study was prematurely terminated due to low recruitment, all analyses were performed using descriptive statistics.
    End point values
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Number of subjects analysed
    49
    55
    Units: subjects
    40
    42
    No statistical analyses for this end point

    Secondary: Number of Subjects with Reduction of Inflammatory Signs and Symptoms After 72 Hours of Treatment

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    End point title
    		 Number of Subjects with Reduction of Inflammatory Signs and Symptoms After 72 Hours of Treatment
    End point description
    Reduction of inflammatory signs and symptoms were defined in primary endpoint. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    72 hours
    End point values
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Number of subjects analysed
    49
    55
    Units: subjects
    48
    53
    No statistical analyses for this end point

    Secondary: Number of Subjects with Reduction of Inflammatory Signs and Symptoms with No Use of Rescue Medication

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    End point title
    		 Number of Subjects with Reduction of Inflammatory Signs and Symptoms with No Use of Rescue Medication
    End point description
    Reduction of inflammatory signs and symptoms were defined in primary endpoint. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    24 hours and 72 hours
    End point values
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Number of subjects analysed
    49
    55
    Units: subjects
        24 hours
    29
    27
        72 hours
    45
    43
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Used Rescue Medication After Randomization

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    End point title
    		 Number of Subjects Who Used Rescue Medication After Randomization
    End point description
    Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    72 hours
    End point values
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Number of subjects analysed
    49
    55
    Units: subjects
    18
    34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 10) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are AEs that developed/worsened during the study period (From the first dose of study drug up to last visit)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Ketoprofen + Amoxicillin
    Reporting group description
    		 Ketoprofen drops for 3 days along with Amoxicillin for 10 days.

    Reporting group title
    Placebo + Amoxicillin
    Reporting group description
    		 Placebo (ketoprofen) drops for 3 days along with Amoxicillin for 10 days.

    Serious adverse events
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ketoprofen + Amoxicillin Placebo + Amoxicillin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    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: Few adverse events were reported during the study period but were below the threshold of 5%

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Dec 2008
    - Amoxicillin dose specification was changed.
    26 Mar 2012
    - Ketoprofen study treatment duration was detailed. - Treatment kits composition was changed.
    10 Apr 2013
    - Amoxicillin treatment dosages were detailed according to the age range. - Instructions for recording the accounting of investigational products was added. - Study Population definition (mITT) was detailed.

    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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