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    Clinical Trial Results:
    A randomised, double-blind, multi-centre, placebo controlled parallel group study to evaluate the efficacy and tolerability of a new Ibuprofen patch in patients with acute sports related traumatic blunt soft tissue injury/contusion to the upper or lower limbs

    Summary
    EudraCT number
    		 2012-003257-29
    Trial protocol
    		 DE  
    Global end of trial date
    02 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2017
    First version publication date
    28 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL1208
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Reckitt Benckiser Healthcare (UK) Ltd
    Sponsor organisation address
    Dansom Lane, Hull, United Kingdom, HU8 7DS
    Public contact
    Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Ltd, 49 2282074318,
    Scientific contact
    Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Ltd, 49 2282074318,
    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
    24 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the efficacy of a new ibuprofen patch versus placebo in the topical treatment of acute sports impact injuries/contusions.
    Protection of trial subjects
    This study was conducted in accordance with ICH Good Clinical Practice and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001/20/EC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 May 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
    Germany: 132
    Worldwide total number of subjects
    132
    EEA total number of subjects
    132
    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)
    132
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted in 3 centres in Germany.

    Pre-assignment
    Screening details
    		 A total of 133 participants were screened of which 132 were randomized and 1 subject withdrew due to Psychotic illness (depression).

    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
    		 Ibuprofen topical patch 200 mg
    Arm description
    		 Ibuprofen Topical patch 200 mg for 5 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nurofen topical patch
    Investigational medicinal product code
    Other name
    Ibuprofen topical patch
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    Ibuprofen Topical patch 200 mg once every 24 hours for 5 days

    Arm title
    		 Placebo topical patch
    Arm description
    		 Placebo topical patch for 5 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo topical patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    Placebo topical patch once every 24 hours for 5 days

    Number of subjects in period 1
    		Ibuprofen topical patch 200 mg Placebo topical patch
    Started
    64
    68
    Completed
    64
    67
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ibuprofen topical patch 200 mg
    Reporting group description
    		 Ibuprofen Topical patch 200 mg for 5 days

    Reporting group title
    Placebo topical patch
    Reporting group description
    		 Placebo topical patch for 5 days

    Reporting group values
    		 Ibuprofen topical patch 200 mg Placebo topical patch Total
    Number of subjects
    		 64 68 132
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 64 68 132
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.2 ± 12.1 30.8 ± 11.2 -
    Gender categorical
    Units: Subjects
        Female
    		 31 39 70
        Male
    		 33 29 62
    Smocking History
    Units: Subjects
        Number of cigarettes/day: None
    		 43 46 89
        Number of cigarettes/day: ≤10
    		 10 12 22
        Number of cigarettes/day: 11-30
    		 11 10 21
    Ethnic origin
    Units: Subjects
        Caucasian
    		 64 67 131
        other
    		 0 1 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 175 ± 9.2 173.3 ± 10.1 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 72.5 ± 13.6 74.2 ± 16.3 -
    BMI
    BMI (Body mass index)
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 23.5 ± 3.3 24.7 ± 3.9 -

    End points

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    End points reporting groups
    Reporting group title
    Ibuprofen topical patch 200 mg
    Reporting group description
    		 Ibuprofen Topical patch 200 mg for 5 days

    Reporting group title
    Placebo topical patch
    Reporting group description
    		 Placebo topical patch for 5 days

    Primary: VAS assessment of pain on movement - Area under curve over 0-72 hours (AUC0-72h)

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    End point title
    		 VAS assessment of pain on movement - Area under curve over 0-72 hours (AUC0-72h)
    End point description
    Intention to treat (ITT) population: All patients who were randomised to the study and received at least one dose of the study medication and had efficacy data for at least one post-baseline assessments. Pain on movement was assessed using a 100 mm Visual Analogue Scale (VAS), by drawing a perpendicular line according to the method of Huskisson, with anchors at 0 = 'No pain' and 100 = 'Unbearable pain'.
    End point type
    Primary
    End point timeframe
    0 (pre-dose) to 72 hour (post-dose)
    End point values
    		 Ibuprofen topical patch 200 mg Placebo topical patch
    Number of subjects analysed
    64
    68
    Units: mm*h
        least squares mean (standard error)
    2399.4 ± 124.8
    4078.9 ± 120.4
    Statistical analysis title
    		 Pain on movement - VAS AUC0-72h
    Comparison groups
    Ibuprofen topical patch 200 mg v Placebo topical patch
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: VAS assessment of pain on movement at Hour 48

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    End point title
    		 VAS assessment of pain on movement at Hour 48
    End point description
    ITT population. Pain on movement was assessed using a 100 mm Visual Analogue Scale (VAS), by drawing a perpendicular line according to the method of Huskisson, with anchors at 0 = 'No pain' and 100 = 'Unbearable pain'.
    End point type
    Secondary
    End point timeframe
    At 48 hour (post-dose)
    End point values
    		 Ibuprofen topical patch 200 mg Placebo topical patch
    Number of subjects analysed
    64
    68
    Units: mm
        least squares mean (standard error)
    23.9 ± 2.1
    50.7 ± 2
    Statistical analysis title
    		 Pain on movement - VAS at hour 48
    Comparison groups
    Ibuprofen topical patch 200 mg v Placebo topical patch
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 5
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Ibuprofen topical patch 200 mg
    Reporting group description
    		 Ibuprofen Topical patch 200 mg once every 24 hours for 5 days

    Reporting group title
    Placebo topical patch
    Reporting group description
    		 Placebo topical patch once every 24 hours for 5 days

    Serious adverse events
    		 Ibuprofen topical patch 200 mg Placebo topical patch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 68 (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 topical patch 200 mg Placebo topical patch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 64 (4.69%)
    6 / 68 (8.82%)
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Application site pruritus
         subjects affected / exposed
    1 / 64 (1.56%)
    5 / 68 (7.35%)
         occurrences all number
    1
    5
    Application site rash
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Eye disorders
    Panophthalmitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Scleral haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 68 (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
    20 Feb 2013
    Protocol updated to stipulate there was a separate dispenser/applier at each site who was not the investigator and that the delegated personnel who did not perform any efficacy assessments was responsible for the handling, storage, dispensing, collecting and administration of the IMP/NIMP
    17 Oct 2013
    The update to the RB SOP ‘Safety Reporting and Definitions’ required an amendment to the RB protocol template and therefore updates to the protocols for On going trials

    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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