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    Clinical Trial Results:
    Multicentre, prospective, double-blind, in parallel groups, randomized, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic lateral epicondylitis (tennis elbow)

    Summary
    EudraCT number
    		 2014-004119-35
    Trial protocol
    		 IT  
    Global end of trial date
    11 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14I-BMT09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBSA Institut Biochimique SA
    Sponsor organisation address
    via del piano 29, Pambio Noranco, Switzerland,
    Public contact
    R&D Scientific Affairs Dept., IBSA Institut Biochimique SA, +41 583601000, sd@ibsa.ch
    Scientific contact
    R&D Scientific Affairs Dept., IBSA Institut Biochimique SA, +41 583601000, sd@ibsa.ch
    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
    12 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to investigate the ability of betamethasone valerate 2.25 mg medicated plaster, as compared to placebo plaster (same formulation but without active ingredient), to significantly reduce pain in patients suffering from chronic lateral elbow tendinopathy, when topically applied daily, according to a 12 hours of application/day dose regimen, and during a period of 4 weeks.
    Protection of trial subjects
    In case of insufficient pain relief, patients were allowed to take the rescue medication (paracetamol 500 mg). If needed, cold applications (up to a maximum of three applications lasting 20 minutes each and performed at least 2 hours before any pain assessment), and braces for casting were allowed, and their use was to be recorded on the patient diary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2015
    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: 199
    Worldwide total number of subjects
    199
    EEA total number of subjects
    199
    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)
    185
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study Initiation Date: (First Patient First Visit) 31 March 2015 Study Completion Date: (Last Patient Last Visit) 11 May 2016

    Pre-assignment
    Screening details
    		 A total of 200 patients were screened and 199 were randomized to the assigned treatment

    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
    		 Investigator, Monitor, Subject, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMV 2.25 mg medicated plaster
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMV 2.25 mg medicated plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    topically applied once a day on the most painful area of the affected body site, i.e. the lateral epicondyle

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    topically applied once a day on the most painful area of the affected body site, i.e. the lateral epicondyle

    Number of subjects in period 1
    		BMV 2.25 mg medicated plaster Placebo
    Started
    101
    98
    Completed
    93
    90
    Not completed
    8
    8
         Consent withdrawn by subject
    7
    3
         Adverse event, non-fatal
    1
    2
         Lost to follow-up
    -
    2
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 199 199
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 185 185
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 94 94
        Male
    		 105 105

    End points

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    End points reporting groups
    Reporting group title
    BMV 2.25 mg medicated plaster
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Pain Reduction

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    End point title
    		 Pain Reduction
    End point description
    End point type
    Primary
    End point timeframe
    Visit 5 (Day 28)
    End point values
    		 BMV 2.25 mg medicated plaster Placebo
    Number of subjects analysed
    94
    90
    Units: mm
        arithmetic mean (standard deviation)
    -36.4 ( 27.0 )
    -25.7 ( 26.4 )
    Statistical analysis title
    		 Primary Endpoint
    Comparison groups
    BMV 2.25 mg medicated plaster v Placebo
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The study period was divided into 5 visits: baseline (Visit 1), Visit 2 (Day 7) Visit 3 (Day 14) Visit 4 (Day 21) Visit 5 (Day 28). Adverse Events were evaluated at each visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    BMV 2.25 mg medicated plaster
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 BMV 2.25 mg medicated plaster Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 98 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BMV 2.25 mg medicated plaster Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 101 (16.83%)
    16 / 98 (16.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 101 (3.96%)
    7 / 98 (7.14%)
         occurrences all number
    4
    8
    Dizziness
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Application site atrophy
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 98 (2.04%)
         occurrences all number
    1
    2
    Application site erythema
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Application site irritation
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Application site pruritus
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         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? 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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