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    Clinical Trial Results:
    Evaluation of the speed of action of Ibuprofen Arginine in comparison to Ibuprofen in the acute pain relief after mini invasive orthopaedic arthroscopic knee surgery in adults.

    Summary
    EudraCT number
    2011-003051-19
    Trial protocol
    IT  
    Global end of trial date
    15 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Dec 2016
    First version publication date
    17 Dec 2016
    Other versions
    Summary report(s)
    CSR synopsis 7190M01

    Trial information

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    Trial identification
    Sponsor protocol code
    Z7190M01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Zambon SpA
    Sponsor organisation address
    via Lillo Del Duca 10, Bresso, Italy,
    Public contact
    Sponsor Contact Person, Zambon S.p.A., 39 026652.41, clinicaltrials@zambongroup.com
    Scientific contact
    Sponsor Contact Person, Zambon S.p.A., 39 026652.41, massimo.bagolan@zambongroup.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 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the speed of action and global clinical efficacy of ibuprofen arginine (IBA) in comparison with ibuprofen (IBU) in patients with postoperative acute pain.
    Protection of trial subjects
    Paracetamol 500 mg tablets were allowed as rescue medication after the first 60 minutes from the study medication intake, and during the following period of study observation according to medical prescription
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Mar 2012
    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
    Italy: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    0
    Adults (18-64 years)
    43
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study population was targeted to include male and female subjects suffering from post-operative acute pain due to mini invasive orthopaedic arthroscopic surgery (meniscectomy) and meeting all the inclusion and exclusion criteria

    Pre-assignment
    Screening details
    Subjects candidate for elective meniscectomy were enrolled at Orthopedic departments

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ibuprofen arginine
    Arm description
    Ibuprofen Arginine (IBA) apricot 600 mg granules for oral solution (sachets); single dose of one sachet
    Arm type
    Experimental

    Investigational medicinal product name
    Ibuprofen arginie
    Investigational medicinal product code
    7190
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    single dose of one sachet 600 mg given by oral route (dissolved in 50 - 100 ml of water) in the post-surgical period

    Arm title
    Ibuprofen
    Arm description
    Ibuprofen (IBU) orange 600 mg granules for oral solution (sachets)
    Arm type
    Active comparator

    Investigational medicinal product name
    Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    single dose of one sachet 600 mg given by oral route (dissolved in 50 - 100 ml of water) in the post-surgical period

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Only the evaluating investigator (observer) was blinded to the treatment administered.
    Number of subjects in period 1
    Ibuprofen arginine Ibuprofen
    Started
    20
    23
    Completed
    20
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ibuprofen arginine
    Reporting group description
    Ibuprofen Arginine (IBA) apricot 600 mg granules for oral solution (sachets); single dose of one sachet

    Reporting group title
    Ibuprofen
    Reporting group description
    Ibuprofen (IBU) orange 600 mg granules for oral solution (sachets)

    Reporting group values
    Ibuprofen arginine Ibuprofen Total
    Number of subjects
    20 23 43
    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)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.4 ± 9.9 40.2 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    1 6 7
        Male
    19 17 36
    Subject analysis sets

    Subject analysis set title
    Safety set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    all subjects randomized and treated with one dose of IMP

    Subject analysis sets values
    Safety set
    Number of subjects
    43
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.2 ± 16.3
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    36

    End points

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    End points reporting groups
    Reporting group title
    Ibuprofen arginine
    Reporting group description
    Ibuprofen Arginine (IBA) apricot 600 mg granules for oral solution (sachets); single dose of one sachet

    Reporting group title
    Ibuprofen
    Reporting group description
    Ibuprofen (IBU) orange 600 mg granules for oral solution (sachets)

    Subject analysis set title
    Safety set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    all subjects randomized and treated with one dose of IMP

    Primary: Onset of pain relief

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    End point title
    Onset of pain relief [1]
    End point description
    The primary endpoint of the study was the time to onset of pain relief (when the subject began to feel any pain relieving effect from the drug) in the first 60 minutes after study medication intake. The effect of IBA or IBU was assessed, for this first 60 minute observation period, in absence of intake of any rescue medication, using a stopwatch clock
    End point type
    Primary
    End point timeframe
    0-360 minutes
    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: The study was prematurely terminated and therefore the sample size is not sufficient for a statistical analysis. Only mean values and SD are reported.
    End point values
    Ibuprofen arginine Ibuprofen
    Number of subjects analysed
    20
    23
    Units: mm
        arithmetic mean (standard deviation)
    -34.8 ± 23.4
    -25 ± 23.1
    No statistical analyses for this end point

    Secondary: achievement of at least 50% pain relief

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    End point title
    achievement of at least 50% pain relief
    End point description
    The proportion of subjects with at least 50% pain relief
    End point type
    Secondary
    End point timeframe
    0-60 minutes
    End point values
    Ibuprofen arginine Ibuprofen
    Number of subjects analysed
    20
    23
    Units: subjects
        Yes
    11
    10
        NO
    9
    13
    No statistical analyses for this end point

    Secondary: Meaningful pain relief

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    End point title
    Meaningful pain relief
    End point description
    The time to achievement of the “meaningful pain relief” (when the subject felt his/her pain relief was meaningful) using a stopwatch clock
    End point type
    Secondary
    End point timeframe
    0-360 minutes
    End point values
    Ibuprofen arginine Ibuprofen
    Number of subjects analysed
    20
    23
    Units: subjects
        Yes
    18
    19
        No
    2
    4
    No statistical analyses for this end point

    Secondary: Clinical Global Impression

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    End point title
    Clinical Global Impression
    End point description
    The Clinical Global Impression (CGI) of the subject at the end of the study, using a 7-point scale
    End point type
    Secondary
    End point timeframe
    0-360 minutes
    End point values
    Ibuprofen arginine Ibuprofen
    Number of subjects analysed
    20
    23
    Units: subjects
        Very much improved
    10
    10
        much improved
    5
    8
        minimally improved
    4
    3
        minimally worse
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signature of Informed Consent to end of study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ibuprofen arginine
    Reporting group description
    -

    Reporting group title
    Ibuprofen
    Reporting group description
    -

    Serious adverse events
    Ibuprofen arginine Ibuprofen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 23 (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
    Ibuprofen arginine Ibuprofen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 23 (4.35%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 23 (4.35%)
         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? Yes
    Date
    Interruption
    Restart date
    15 Jul 2014
    The study was interrupted because of slow recruitment and difficulty in enrolling subjects
    -

    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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