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    Clinical Trial Results:
    Evaluation of efficacy and safety of Ibuprofen Arginine 600 mg tid vs. Ibuprofen 600 mg tid in the treatment of pain and inflammation in Osteoarthritis (OA) patients with hypertension pharmacologically stabilized.

    Summary
    EudraCT number
    		 2011-003826-28
    Trial protocol
    		 IT  
    Global end of trial date
    09 Dec 2013

    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 Z7190L01

    Trial information

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    Trial identification
    Sponsor protocol code
    Z7190L01
    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 Point, Zambon S.p.A., +39 0266524513, clinicaltrials@zambongroup.com
    Scientific contact
    Sponsor Contact Point, Zambon S.p.A., +39 0266524513, clinicaltrials@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
    23 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of the study is to compare IBA vs. IBU in the change from baseline of daily spontaneous pain in patients suffering from OA and stabilized hypertension.
    Protection of trial subjects
    No specific measures were in place. The test and reference products are marketed products.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2013
    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: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    4
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed in Italy at 4 investigational study sites (public hospitals). Patients were affected by osteoarthitis (OA) with hypetension.

    Pre-assignment
    Screening details
    		 After signing the informed consent, patients with OA and stabilized hypertension by pharmacological treatment in monotherapy or with no more than three antihypertensive drugs association among AT1 antagonists or ACE inhibitors or Calcium-channel-blockers or diuretics .

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ibuprofen arginine
    Arm description
    		 14 days treatment with Ibuprofen Arginine apricot 600 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen arginine
    Investigational medicinal product code
    Z7190
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    600 mg three times daily

    Arm title
    		 Ibuprofen
    Arm description
    		 14 days treatment with ibuprofen 600 mg
    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
    600 mg three times daily

    Number of subjects in period 1
    		Ibuprofen arginine Ibuprofen
    Started
    5
    5
    Completed
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ibuprofen arginine
    Reporting group description
    		 14 days treatment with Ibuprofen Arginine apricot 600 mg

    Reporting group title
    Ibuprofen
    Reporting group description
    		 14 days treatment with ibuprofen 600 mg

    Reporting group values
    		 Ibuprofen arginine Ibuprofen Total
    Number of subjects
    		 5 5 10
    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)
    		 70.6 ( 7.9 ) 68.3 ( 8.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 5 8
        Male
    		 2 0 2
    Subject analysis sets

    Subject analysis set title
    FAS IBA
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    only 5 randomized subjects who took one dose of IMP are reported. Study has been interrupted and therefore no formal analysis has been performed

    Subject analysis set title
    FAS IBU
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    only 5 randomized subjects who took one dose of IMP are reported. Study has been interrupted and therefore no formal analysis has been performed

    Subject analysis sets values
    		 FAS IBA FAS IBU
    Number of subjects
    5
    5
    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)
    67.1 ( 8.7 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    8
        Male
    2

    End points

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    End points reporting groups
    Reporting group title
    Ibuprofen arginine
    Reporting group description
    		 14 days treatment with Ibuprofen Arginine apricot 600 mg

    Reporting group title
    Ibuprofen
    Reporting group description
    		 14 days treatment with ibuprofen 600 mg

    Subject analysis set title
    FAS IBA
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    only 5 randomized subjects who took one dose of IMP are reported. Study has been interrupted and therefore no formal analysis has been performed

    Subject analysis set title
    FAS IBU
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    only 5 randomized subjects who took one dose of IMP are reported. Study has been interrupted and therefore no formal analysis has been performed

    Primary: change versus baseline of daily spontaneous pain on VAS

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    End point title
    		 change versus baseline of daily spontaneous pain on VAS [1]
    End point description
    End point type
    Primary
    End point timeframe
    change from Day 0 to Day 14
    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: Due to study prematurely termination, no formal statistical analysis has been performed due to low number of subjects
    End point values
    		 Ibuprofen arginine Ibuprofen FAS IBA FAS IBU
    Number of subjects analysed
    5
    5
    5
    5
    Units: mm
        arithmetic mean (standard deviation)
    58.8 ( 30.8 )
    57.6 ( 25.5 )
    41 ( 39.4 )
    45.2 ( 32.2 )
    No statistical analyses for this end point

    Secondary: Daily morning stiffness

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    End point title
    		 Daily morning stiffness
    End point description
    End point type
    Secondary
    End point timeframe
    from day 0 to day 14
    End point values
    		 Ibuprofen arginine Ibuprofen FAS IBA FAS IBU
    Number of subjects analysed
    5
    5
    5
    5
    Units: mm
        arithmetic mean (standard deviation)
    60.6 ( 25.2 )
    50.8 ( 25.3 )
    40.3 ( 39.1 )
    44.8 ( 32.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from enrolment to end of study (e.g. day 14)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    safety population IBA
    Reporting group description
    		 all subjects treated with at least one dose of IMP

    Reporting group title
    Safety Population IBU
    Reporting group description
    		 -

    Serious adverse events
    		 safety population IBA Safety Population IBU
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (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
    		 safety population IBA Safety Population IBU
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2012
    This amendment changed the method for the assessment of kidney disease as exclusion criterion, i.e. the Cockcroft-Gault formula was replaced with the MDRD formula, as it was considered as more reliable than the Cockcroft-Gault formula. With the MDRD formula, a value of estimated GFR below 60 ml/min is indicative of chronic renal disease.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Dec 2013
    It was initially expected that recruitment would be completed over a period of one year starting from the 2nd quarter of 2012. The actual recruitment was slower than expected and recruitment was eventually terminated in November 2013 with only 10 patients randomized.
    -

    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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