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    Clinical Trial Results:
    A randomized, multicenter trial of oseltamivir doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days in influenza patients with pandemic (H1N1) 2009

    Summary
    EudraCT number
    2016-001008-49
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    28 Jun 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Mar 2017
    First version publication date
    07 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NV22155
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01032837
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche Ltd
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jun 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To prospectively evaluate the efficacy of four regimens of oseltamivir on the duration of viral shedding in patients infected with pandemic (H1N1) 2009.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. A Data Review committee (DRC) supervised the participants’ safety and performed the pre-specified interim analyses according to the protocol. Before entering the study, the informed consent form was read by and explained to all participants and/or their legally authorized representative. Participants signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Nov 2009
    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
    United States: 101
    Worldwide total number of subjects
    101
    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)
    4
    Children (2-11 years)
    21
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    65
    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 27 centers in the United States (US). In all, 102 participants were enrolled in this study and 101 received the study medication

    Pre-assignment
    Screening details
    Overall, 574 participants were screened during the study; 102 were randomized to receive study treatment and one patient withdrew consent prior to first dose. There were 472 screen failures and the main reason for screen failures were a result of a negative rapid influenza test.

    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
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Oseltamivir Standard Dose 5 Days
    Arm description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Adults and children 13 years and older received 75mg oral capsule two times a day for five days.

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension orally twice daily for five days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Adults and children 13 years and older received 75 mg matching oral placebo capsule twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) matching placebo suspension orally twice daily for five days. Participants received matching placebo for the second 5 days of treatment.

    Arm title
    Oseltamivir Standard Dose 10 Days
    Arm description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Adults and children 13 years and older received 75mg oral capsule two times a day for ten days.

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension orally twice daily for ten days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Adults and children 13 years and older received 75 mg matching oral placebo capsule twice daily for 10 days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) matching placebo suspension orally twice daily for ten days.

    Arm title
    Oseltamivir High Dose 5 Days
    Arm description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir oral capsule two times a day for five days.

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for five days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received matching placebo for the second 5 days of treatment.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received matching placebo for the second 5 days of treatment.

    Arm title
    Oseltamivir High Dose 10 Days
    Arm description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days
    Arm type
    Experimental

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days.

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Ro 64-0796
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.

    Number of subjects in period 1
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Started
    26
    26
    25
    24
    Completed
    26
    23
    24
    22
    Not completed
    0
    3
    1
    2
         Refused treatment
    -
    -
    -
    1
         Adverse event, not serious
    -
    1
    -
    1
         Consent withdrawn by subject
    -
    2
    -
    -
         Lost to follow-up
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oseltamivir Standard Dose 5 Days
    Reporting group description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Reporting group title
    Oseltamivir Standard Dose 10 Days
    Reporting group description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.

    Reporting group title
    Oseltamivir High Dose 5 Days
    Reporting group description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Reporting group title
    Oseltamivir High Dose 10 Days
    Reporting group description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days

    Reporting group values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days Total
    Number of subjects
    26 26 25 24 101
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 2 1 1 4
        Children (2-11 years)
    6 4 6 5 21
        Adolescents (12-17 years)
    2 2 4 3 11
        Adults (18-64 years)
    18 18 14 15 65
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    28 ± 17.84 27.3 ± 17.42 27.2 ± 20.7 22.4 ± 14.39 -
    Gender categorical
    Units: Subjects
        Female
    13 15 14 12 54
        Male
    13 11 11 12 47

    End points

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    End points reporting groups
    Reporting group title
    Oseltamivir Standard Dose 5 Days
    Reporting group description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Reporting group title
    Oseltamivir Standard Dose 10 Days
    Reporting group description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.

    Reporting group title
    Oseltamivir High Dose 5 Days
    Reporting group description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Reporting group title
    Oseltamivir High Dose 10 Days
    Reporting group description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days

    Primary: Time to Cessation of Viral Shedding

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    End point title
    Time to Cessation of Viral Shedding [1]
    End point description
    The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 40
    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: Study data were analyzed by descriptive summaries. No formal hypothesis testing was planned.
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: hours
    median (confidence interval 95%)
        Time to Cessation of Viral Shedding
    65.6 (47.5 to 79.9)
    70.8 (62.1 to 101.7)
    58.1 (27.3 to 93.3)
    74.1 (48.6 to 117.5)
    No statistical analyses for this end point

    Secondary: Number of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture

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    End point title
    Number of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture
    End point description
    Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory. Only the numbers of participants available at the particular time point were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 3, 6, 8, 11, 15 and 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: Percentage of Participants
        Baseline (n=19, 18, 16, 17)
    19
    18
    16
    17
        Day 3 (n=19, 17, 15, 15)
    7
    11
    7
    9
        Day 6 (n=19, 17, 15, 15)
    0
    0
    1
    2
        Day 8 (n=18, 17, 15, 15)
    1
    0
    0
    1
        Day 11 (n=18, 18, 15, 14)
    1
    2
    0
    0
        Day 15 (n=18, 14, 15, 12)
    0
    0
    0
    0
        Day 40 (n=16, 15, 16, 14)
    1
    2
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction

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    End point title
    Number of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction
    End point description
    Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory. Only the numbers of participants available at the particular time point were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 3, 6, 8, 11, 15 and 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: Percentage of Participants
        Baseline (n=19, 18, 16, 17)
    17
    18
    16
    17
        Day 3 (n=19, 17, 15, 15)
    15
    15
    11
    13
        Day 6 (n=19, 17, 15, 15)
    5
    5
    8
    8
        Day 8 (n=18, 17, 15, 15)
    2
    2
    2
    2
        Day 11 (n=18, 18, 15, 14)
    1
    1
    4
    3
        Day 15 (n=18, 14, 15, 12)
    0
    1
    0
    1
        Day 40 (n=16, 15, 16, 14)
    1
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Influenza Titer Measured by Viral Culture

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    End point title
    Change From Baseline in Influenza Titer Measured by Viral Culture
    End point description
    Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2 through 15
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: Log10 TCID50
    arithmetic mean (standard deviation)
        Baseline (n=19, 18, 16, 17)
    3.74 ± 1.478
    4.06 ± 1.235
    4.14 ± 1.338
    4.54 ± 0.746
        Day 2 (n=19, 18, 15, 17)
    -1.82 ± 1.457
    -1.17 ± 1.138
    -1.97 ± 1.584
    -1.15 ± 1.425
        Day 3 (n=19, 18, 15, 17)
    -2.38 ± 1.67
    -2.18 ± 1.221
    -2.95 ± 1.286
    -2.88 ± 1.296
        Day 4 (n=19, 18, 15, 17)
    -3.18 ± 1.511
    -3.29 ± 1.129
    -3.33 ± 1.368
    -3.76 ± 0.859
        Day 5 (n=19, 18, 16, 17)
    -3 ± 1.656
    -3.43 ± 1.14
    -3.45 ± 1.453
    -3.91 ± 0.765
        Day 6 (n=19, 18, 15, 17)
    -3.22 ± 1.488
    -3.56 ± 1.235
    -3.45 ± 1.53
    -3.99 ± 0.726
        Day 7 (n=19, 18, 16, 17)
    -3.22 ± 1.469
    -3.53 ± 1.218
    -3.58 ± 1.331
    -4.04 ± 0.746
        Day 8 (n=19, 18, 15, 17)
    -3.18 ± 1.457
    -3.56 ± 1.235
    -3.65 ± 1.385
    -4.04 ± 0.746
        Day 9 (n=19, 18, 14, 16)
    -3.24 ± 1.478
    -3.53 ± 1.218
    -3.57 ± 1.381
    -4.08 ± 0.688
        Day 10 (n=19, 18, 15, 16)
    -3.21 ± 1.463
    -3.5 ± 1.26
    -3.55 ± 1.334
    -4.14 ± 0.652
        Day 11 (n=19, 16, 16, 15)
    -3.22 ± 1.469
    -3.42 ± 1.524
    -3.64 ± 1.338
    -4.08 ± 0.632
        Day 12 (n=19, 18, 15, 15)
    -3.11 ± 1.669
    -3.47 ± 1.289
    -3.63 ± 1.385
    -4.1 ± 0.653
        Day 13 (n=19, 18, 16, 15)
    -3.17 ± 1.458
    -3.43 ± 1.248
    -3.64 ± 1.338
    -4.1 ± 0.653
        Day 14 (n=18, 18, 15, 15)
    -3.17 ± 1.488
    -3.56 ± 1.235
    -3.55 ± 1.334
    -4.1 ± 0.653
        Day 15 (n=18, 17, 14, 15)
    -3.14 ± 1.456
    -3.5 ± 1.25
    -3.55 ± 1.401
    -4.1 ± 0.653
    No statistical analyses for this end point

    Secondary: Number of Participants With Development of Oseltamivir-Resistant Influenza Virus

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    End point title
    Number of Participants With Development of Oseltamivir-Resistant Influenza Virus
    End point description
    The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.
    End point type
    Secondary
    End point timeframe
    40 Days
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: Number of Participants
        Development of Oseltamivir-Resistant Influenza
    0
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Time to Resolution of Fever

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    End point title
    Time to Resolution of Fever
    End point description
    Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    10
    6
    8
    3
    Units: Hours
    median (confidence interval 95%)
        Time to Resolution of Fever
    19.3 (10.6 to 58.4)
    35.5 (12.7 to 53.1)
    24.9 (15.7 to 45.2)
    20 (15.9 to 74.3)
    No statistical analyses for this end point

    Secondary: Time to Alleviation of All Clinical Symptoms - Children

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    End point title
    Time to Alleviation of All Clinical Symptoms - Children
    End point description
    Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    6
    4
    4
    3
    Units: hours
    median (confidence interval 95%)
        Time to Alleviation of All Clinical Symptoms
    176.8 (67.5 to 302)
    127.7 (32.6 to 281.8)
    118.8 (46.3 to 228.2)
    123.1 (7.1 to 232.3)
    No statistical analyses for this end point

    Secondary: Time to Alleviation of All Clinical Symptoms - Adults

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    End point title
    Time to Alleviation of All Clinical Symptoms - Adults
    End point description
    Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    13
    14
    12
    14
    Units: hours
    median (confidence interval 95%)
        Time to Alleviation of All Clinical Symptoms
    140 (99.8 to 183.1)
    181.8 (87 to 354.6)
    146.8 (109.1 to 237.8)
    94.9 (57.2 to 261.2)
    No statistical analyses for this end point

    Secondary: Number of Participants Who Developed Secondary Illnesses During the Study

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    End point title
    Number of Participants Who Developed Secondary Illnesses During the Study
    End point description
    The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: Number of Participants
        Bronchitis
    1
    0
    0
    0
        Otitis media
    0
    0
    0
    0
        Pneumonia
    0
    0
    0
    0
        Sinusitis
    0
    0
    0
    2
        Any secondary illness
    1
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics

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    End point title
    Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics
    End point description
    The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 40
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    19
    18
    16
    17
    Units: Number of Participants
    0
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with any Adverse Event (AE) or Serious Adverse Event (SAE)

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    End point title
    Number of Participants with any Adverse Event (AE) or Serious Adverse Event (SAE)
    End point description
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.
    End point type
    Secondary
    End point timeframe
    Up to 1 year
    End point values
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Number of subjects analysed
    26
    26
    25
    24
    Units: Number of Participants
        Total patients with at least one AE
    10
    11
    7
    10
        Total number of AE’s
    17
    15
    9
    19
        Total number of SAE’s
    0
    0
    0
    0
        Total number of Deaths
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 40
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Oseltamivir Standard Dose 5 Days
    Reporting group description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Reporting group title
    Oseltamivir Standard Dose 10 Days
    Reporting group description
    Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.

    Reporting group title
    Oseltamivir High Dose 5 Days
    Reporting group description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

    Reporting group title
    Oseltamivir High Dose 10 Days
    Reporting group description
    Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days

    Serious adverse events
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    5 / 26 (19.23%)
    3 / 25 (12.00%)
    6 / 24 (25.00%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    6 / 24 (25.00%)
         occurrences all number
    0
    3
    0
    7
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    1 / 25 (4.00%)
    2 / 24 (8.33%)
         occurrences all number
    1
    1
    2
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Oct 2009
    This protocol amendment included addition of the exclusion criterion for vaccination with live attenuated influenza vaccine and Inclusion of patients with influenza A without further specification of pandemic influenza A (H1N1) 2009

    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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