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    Clinical Trial Results:
    An Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release (IR) Or Extended-Release (ER) Formulation In Pediatric Subjects With Acute Otitis Media (AOM)

    Summary
    EudraCT number
    		 2014-004164-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Feb 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2016
    First version publication date
    15 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A0661190
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00796224
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.govCallCenter@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.govCallCenter@pfizer.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
    23 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the pharmacokinetics of azithromycin following a single dose of either 30 milligram per kilogram (mg/kg) IR or 60 mg/kg ER formulation in pediatric subjects with AOM.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Dec 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
    Costa Rica: 38
    Worldwide total number of subjects
    38
    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)
    19
    Children (2-11 years)
    19
    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
    		 -

    Pre-assignment
    Screening details
    		 Study started on 23 December 2008 and completed on 18 February 2009 in Costa Rica. Subjects were screened within 48 hours of dosing.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 60 mg/kg Azithromycin Extended-release (ER)
    Arm description
    		 Subjects received Azithromycin ER single oral dose on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.

    Arm title
    		 30 mg/kg Azithromycin Immediate-release (IR)
    Arm description
    		 Subjects received Azithromycin IR single oral dose on Day 1.
    Arm type
    		 Reference

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.

    Number of subjects in period 1
    		60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Started
    19
    19
    Completed
    18
    18
    Not completed
    1
    1
         Adverse event
    1
    -
         Protocol Violation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    60 mg/kg Azithromycin Extended-release (ER)
    Reporting group description
    		 Subjects received Azithromycin ER single oral dose on Day 1.

    Reporting group title
    30 mg/kg Azithromycin Immediate-release (IR)
    Reporting group description
    		 Subjects received Azithromycin IR single oral dose on Day 1.

    Reporting group values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR) Total
    Number of subjects
    		 19 19 38
    Age categorical
    Units: Subjects
        1 month to less than (<) 2 years
    		 13 6 19
        2 years to <12 years
    		 6 13 19
    Gender categorical
    Units: Subjects
        Female
    		 8 7 15
        Male
    		 11 12 23

    End points

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    End points reporting groups
    Reporting group title
    60 mg/kg Azithromycin Extended-release (ER)
    Reporting group description
    		 Subjects received Azithromycin ER single oral dose on Day 1.

    Reporting group title
    30 mg/kg Azithromycin Immediate-release (IR)
    Reporting group description
    		 Subjects received Azithromycin IR single oral dose on Day 1.

    Primary: Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)

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    End point title
    		 Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
    End point description
    AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours. All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.
    End point type
    Primary
    End point timeframe
    Pre-dose/ 0 to 72 hours
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    18
    18
    Units: nanogram*hour per milliliter (ng*hr/mL)
        arithmetic mean (standard deviation)
    12173.02 ( 6305.032 )
    7950.949 ( 4759.301 )
    Statistical analysis title
    		 Analysis of AUC72
    Statistical analysis description
    Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR). Analysis of variance (ANOVA) method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric Means
    Point estimate
    157.98
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 98.87
         upper limit
    		 252.44

    Secondary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)

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    End point title
    		 Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)
    End point description
    AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.
    End point type
    Secondary
    End point timeframe
    Pre-dose /0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    18
    18
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    15536.19 ( 9310.399 )
    9645.63 ( 6062.67 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Azithromycin

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Azithromycin
    End point description
    All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.
    End point type
    Secondary
    End point timeframe
    Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    18
    18
    Units: ng/mL
        arithmetic mean (standard deviation)
    774.75 ( 477.989 )
    901.644 ( 600.682 )
    Statistical analysis title
    		 Analysis of Cmax
    Statistical analysis description
    ANOVA method was used for analysis.
    Comparison groups
    30 mg/kg Azithromycin Immediate-release (IR) v 60 mg/kg Azithromycin Extended-release (ER)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric Means
    Point estimate
    91.63
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 56.21
         upper limit
    		 149.38

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin
    End point description
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half. All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.
    End point type
    Secondary
    End point timeframe
    Pre dose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    18
    18
    Units: hour
    median (full range (min-max))
        Tmax
    3 (2 to 8)
    2 (1 to 4.05)
        t1/2
    30.303 (15 to 52.2)
    28.959 (10.4 to 49)
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)

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    End point title
    		 Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)
    End point description
    All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.
    End point type
    Secondary
    End point timeframe
    1, 2, 3, 4, 8, 24, 48, 72 hours
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    18
    18
    Units: ng/mL
    number (not applicable)
        Serum Concentration 1 hour post dose
    99.96
    152.75
        Serum Concentration 2 hour postdose
    293.14
    579.72
        Serum concentration 3 hour postdose
    381.96
    381.69
        Serum Concentration 4 hour postdose
    441.79
    267.86
        Serum Concentration 8 hour postdose
    244.75
    140.33
        Serum Concentration 24 hour postdose
    142.41
    82.31
        Serum Concentration 48 hour postdose
    94.79
    50.06
        Serum Concentration 72 hour postdose
    56.03
    30.6
    Statistical analysis title
    		 Serum Concentration 1 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    65.44
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 23.56
         upper limit
    		 181.77
    Statistical analysis title
    		 Serum Concentration 2 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    50.57
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 25.24
         upper limit
    		 101.3
    Statistical analysis title
    		 Serum Concentration 3 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    100.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 57.91
         upper limit
    		 172.92
    Statistical analysis title
    		 Serum Concentration 4 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    164.93
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 103.78
         upper limit
    		 262.12
    Statistical analysis title
    		 Serum Concentration 8 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    174.41
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 110.07
         upper limit
    		 276.36
    Statistical analysis title
    		 Serum Concentration 24 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    173.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 111.45
         upper limit
    		 268.55
    Statistical analysis title
    		 Serum Concentration 48 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    189.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 129.76
         upper limit
    		 276.3
    Statistical analysis title
    		 Serum Concentration 72 hour postdose
    Statistical analysis description
    Ratio (percent) = Test/Reference multiplied by 100. ANOVA method was used for analysis.
    Comparison groups
    60 mg/kg Azithromycin Extended-release (ER) v 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Ratio of Geometric means (percent)
    Point estimate
    183.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 124.61
         upper limit
    		 269.14

    Secondary: Number of Subjects With a Clinical Response

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    End point title
    		 Number of Subjects With a Clinical Response
    End point description
    Clinical response was assessed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following: Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary; New clinical signs and symptoms of acute illness have developed and additional therapy is necessary. Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.
    End point type
    Secondary
    End point timeframe
    Day 7, 8, 9 or 10
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    18
    18
    Units: subjects
        Cure
    18
    16
        Failure
    0
    2
    No statistical analyses for this end point

    Secondary: Adverse Events (AEs) and Serious AEs (SAEs)

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    End point title
    		 Adverse Events (AEs) and Serious AEs (SAEs)
    End point description
    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported. All subjects who received at least 1 dose of study medication were included in the safety analyses.
    End point type
    Secondary
    End point timeframe
    Baseline up to 35 days of last study treatment
    End point values
    		 60 mg/kg Azithromycin Extended-release (ER) 30 mg/kg Azithromycin Immediate-release (IR)
    Number of subjects analysed
    19
    19
    Units: subjects
        AEs
    4
    5
        SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline till 35 days after last study treatment
    Adverse event reporting additional description
    EU BR specific AE tables were generated separately as per EU format. Latest coding dictionary has been used for EU BR tables.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    60 mg/kg Azithromycin ER
    Reporting group description
    		 Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.

    Reporting group title
    30 mg/kg Azithromycin IR
    Reporting group description
    		 Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.

    Serious adverse events
    		 60 mg/kg Azithromycin ER 30 mg/kg Azithromycin IR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (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: 0%
    Non-serious adverse events
    		 60 mg/kg Azithromycin ER 30 mg/kg Azithromycin IR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 19 (21.05%)
    5 / 19 (26.32%)
    General disorders and administration site conditions
    Treatment failure
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    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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