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    Clinical Trial Results:
    Randomised, Double Dummy, Placebo Controlled, Multicentre, Parallel-Group, Single Dose Study to Compare the Analgesic Efficacy and Safety of IBALGIN Extra Fast /ibuprofen lysin/ to conventional Ibuprofen in the Treatment of Acute Pain

    Summary
    EudraCT number
    		 2006-006942-33
    Trial protocol
    		 CZ  
    Global end of trial date
    13 Mar 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2016
    First version publication date
    14 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13/06/IBL/TP3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zentiva k.s
    Sponsor organisation address
    U kabelovny 130 , Praha 10 - Dolní Měcholupy, Czech Republic, 102 37
    Public contact
    MUDr. Tomas Hauser, Zentiva k.s, 00420 267243451, Tomas.Hauser@sanofi.com
    Scientific contact
    MUDr. Tomas Hauser, Zentiva k.s, 00420 267243451, Tomas.Hauser@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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Mar 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that: 1. Ibalgin Extra Fast® is superior over placebo in overall analgesic efficacy. This conclusion will be drawn if and only if the lower limit of the two-sided 95% confidence interval for the treatment difference (test-placebo) in TOTPAR is greater than zero. 2. Ibalgin Extra Fast® is non-inferior to Nurofen forte® (the active comparator) in overall analgesic efficacy. This conclusion will be drawn if and only if 1. is concluded and two-sided 95% confidence interval for the treatment difference (test-active comparator) in TOTPAR lies entirely to the right of the non-inferiority margin. 3. Ibalgin Extra Fast® is superior over Nurofen forte® (the active comparator) in the onset of action. This conclusion will be drawn if and only if 2. is concluded and the lower limit of the two-sided 95% confidence interval for the treatment difference (test-active comparator) in PAR45 is greater than zero.
    Protection of trial subjects
    No specific measurements required
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    25 May 2007
    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
    Czech Republic: 351
    Worldwide total number of subjects
    351
    EEA total number of subjects
    351
    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)
    2
    Adults (18-64 years)
    349
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 25 May 2007 Nine centres

    Pre-assignment
    Screening details
    		 Subject indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone. inclusion/exclusion criteria check-list, medical history/ physical examination, laboratory examination: clinical chemistry, urinalysis, haematology, serology

    Period 1
    Period 1 title
    Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    A double-dummy technique was used dou to the differences between IBALGIN Extra fast(R) and Nurofen forte(R). The medication was administered by study nurse.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IBALGIN Extra Fast(R)
    Arm description
    		 This arm includes subjects receiving the IBALGIN Extra Fast(R) medication
    Arm type
    		 Experimental

    Investigational medicinal product name
    IBALGIN Extra Fast
    Investigational medicinal product code
    NA
    Other name
    NA
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg of ibuprofen as lysine salt, oral administration

    Arm title
    		 NUROFEN FORTE(R)
    Arm description
    		 This arm includes patient receiving NUROFEN FORTE(R) as a medication.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NUROFEN FORTE(R)
    Investigational medicinal product code
    NA
    Other name
    NA
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg of ibuprofen, oral administration

    Arm title
    		 Placebo
    Arm description
    		 This arm includes patients receiving placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 mg of ibuprofen, oral administration

    Number of subjects in period 1
    		IBALGIN Extra Fast(R) NUROFEN FORTE(R) Placebo
    Started
    141
    139
    71
    Completed
    141
    139
    71

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IBALGIN Extra Fast(R)
    Reporting group description
    		 This arm includes subjects receiving the IBALGIN Extra Fast(R) medication

    Reporting group title
    NUROFEN FORTE(R)
    Reporting group description
    		 This arm includes patient receiving NUROFEN FORTE(R) as a medication.

    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes patients receiving placebo.

    Reporting group values
    		 IBALGIN Extra Fast(R) NUROFEN FORTE(R) Placebo Total
    Number of subjects
    		 141 139 71 351
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 1 1 2
        Adults (18-64 years)
    		 141 138 70 349
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.7 ( 7.5 ) 28.5 ( 8.2 ) 27.5 ( 7.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 83 87 40 210
        Male
    		 58 52 31 141
    Subject analysis sets

    Subject analysis set title
    Subject analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects used for analysis of data from both study periods.

    Subject analysis sets values
    		 Subject analysis set
    Number of subjects
    351
    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)
    2
        Adults (18-64 years)
    349
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    28.2 ( 7.9 )
    Gender categorical
    Units: Subjects
        Female
    210
        Male
    141

    End points

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    End points reporting groups
    Reporting group title
    IBALGIN Extra Fast(R)
    Reporting group description
    		 This arm includes subjects receiving the IBALGIN Extra Fast(R) medication

    Reporting group title
    NUROFEN FORTE(R)
    Reporting group description
    		 This arm includes patient receiving NUROFEN FORTE(R) as a medication.

    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes patients receiving placebo.

    Subject analysis set title
    Subject analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects used for analysis of data from both study periods.

    Primary: TOTPAR6

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    End point title
    		 TOTPAR6
    End point description
    Pain relief (PAR) was rated on a standard five-point scale (0-4) using following description: 0 = none 1 = a little 2 = some 3 = a lot 4 = complete Patients recorded their pain relief at regularly sheduled intervals (15, 30, 45, 60, 90 min and 2, 3, 4, 5 and 6 hours) after having taken the study medication. For the purposes of primary objectives, Total Pain Relief at 6 hours (TOTPAR6, calculated as the weighted sum of the pain relief scores at 6 hours) and time specific PAR at 45 min (PAR45) were evaluated based on PAR measurements.
    End point type
    Primary
    End point timeframe
    comparison of data from whole period
    End point values
    		 IBALGIN Extra Fast(R) NUROFEN FORTE(R) Placebo
    Number of subjects analysed
    141
    139
    71
    Units: TOTPAR
        arithmetic mean (standard error)
    19.57 ( 1.08 )
    19.96 ( 1.14 )
    8.27 ( 1.36 )
    Statistical analysis title
    		 TOTPAR6 - Ibalgin vs. Nurofen
    Comparison groups
    IBALGIN Extra Fast(R) v NUROFEN FORTE(R)
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.74
         upper limit
    		 1.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [1] - ANOVA
    Statistical analysis title
    		 TOTPAR6 - Ibalgin vs. Placebo
    Comparison groups
    IBALGIN Extra Fast(R) v Placebo
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.45
         upper limit
    		 14.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.45
    Notes
    [2] - ANOVA
    Statistical analysis title
    		 TOTPAR6 - Nurofen vs. Placebo
    Comparison groups
    NUROFEN FORTE(R) v Placebo
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.83
         upper limit
    		 14.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.46
    Notes
    [3] - ANOVA

    Primary: PAR45

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    End point title
    		 PAR45
    End point description
    End point type
    Primary
    End point timeframe
    comparison of data from the whole study period
    End point values
    		 IBALGIN Extra Fast(R) NUROFEN FORTE(R) Placebo
    Number of subjects analysed
    141
    139
    71
    Units: PAR45
        arithmetic mean (standard error)
    1.92 ( 0.13 )
    1.67 ( 0.13 )
    0.62 ( 0.16 )
    Statistical analysis title
    		 PAR45 - Ibalgin vs. Nurofen
    Comparison groups
    IBALGIN Extra Fast(R) v NUROFEN FORTE(R)
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [4] - ANOVA
    Statistical analysis title
    		 PAR45 - Ibalgin vs. Placebo
    Comparison groups
    IBALGIN Extra Fast(R) v Placebo
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Notes
    [5] - ANOVA
    Statistical analysis title
    		 PAR45 - Nurofen vs Placebo
    Comparison groups
    NUROFEN FORTE(R) v Placebo
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Notes
    [6] - ANOVA

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For whole study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 280 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 280 (4.64%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Wound complication
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Wound dehiscence
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Seroma
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Procedural pain
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Post procedural oedema
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Procedural headache
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    4 / 280 (1.43%)
         occurrences all number
    4
    Pain
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Oral administration complication
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Swelling face
         subjects affected / exposed
    2 / 280 (0.71%)
         occurrences all number
    2
    Infections and infestations
    Alveolar osteitis
         subjects affected / exposed
    1 / 280 (0.36%)
         occurrences all number
    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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