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    Clinical Trial Results:
    Multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of two different treatment regimens of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic tendinopathies of the upper and lower limbs

    Summary
    EudraCT number
    		 2012-005030-11
    Trial protocol
    		 IT  
    Global end of trial date
    24 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2019
    First version publication date
    13 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12I-BMT08
    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
    Stefano Rovati, IBSA Institut Biochimique SA, +41 583600000, stefano.rovati@ibsa.ch
    Scientific contact
    Stefano Rovati, IBSA Institut Biochimique SA, +41 583600000, stefano.rovati@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
    08 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2014
    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 reduce pain when topically applied daily, according to two different dose regimens (i.e., 12 or 24 hours of application/day), and during a period of 4 weeks, in patients suffering from chronic lateral elbow tendinopathy and chronic midportion Achilles tendinopathy.
    Protection of trial subjects
    In case of insufficient pain relief, patients were allowed to take paracetamol 500 mg oral tablet as rescue medication, up to a maximum daily dose of 4 g.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 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: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    95
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study Initiation Date: (First Patient First Visit) 24 Apr 2013 Study Completion Date: (Last Patient Last Visit) 06 Feb 2014

    Pre-assignment
    Screening details
    		 Patients suffering from ≥12 weeks of either from Chronic Lateral Elbow Tendinopathy or Chronic Midportion (or non-insertional) Achilles Tendinopathy in their symptomatic phase, defined as a pain ≥ 50 mm on a 0-100 mm VAS as perceived when performing a standardized movement

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMV plaster 24h
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMV plaster 24h
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    One single plaster was topically applied once a day for 24 hours

    Arm title
    		 BMV plaster 12h
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMV plaster 12h
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    One single plaster was topically applied once a day for 12 hours

    Arm title
    		 PBO plaster
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    PBO plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    One single plaster was topically applied once a day for 12 or 24 hours

    Number of subjects in period 1
    		BMV plaster 24h BMV plaster 12h PBO plaster
    Started
    37
    32
    33
    Completed
    35
    32
    29
    Not completed
    2
    0
    4
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    2
         Lack of efficacy
    -
    -
    1
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMV plaster 24h
    Reporting group description
    		 -

    Reporting group title
    BMV plaster 12h
    Reporting group description
    		 -

    Reporting group title
    PBO plaster
    Reporting group description
    		 -

    Reporting group values
    		 BMV plaster 24h BMV plaster 12h PBO plaster Total
    Number of subjects
    		 37 32 33 102
    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 0 0 0
        Adults (18-64 years)
    		 32 30 32 94
        From 65-84 years
    		 5 2 1 8
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 17 12 19 48
        Male
    		 20 20 14 54

    End points

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    End points reporting groups
    Reporting group title
    BMV plaster 24h
    Reporting group description
    		 -

    Reporting group title
    BMV plaster 12h
    Reporting group description
    		 -

    Reporting group title
    PBO plaster
    Reporting group description
    		 -

    Primary: VAS Pain Reduction

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    End point title
    		 VAS Pain Reduction
    End point description
    End point type
    Primary
    End point timeframe
    decrease of VAS Pain score (mm) from baseline to Day 28
    End point values
    		 BMV plaster 24h BMV plaster 12h PBO plaster
    Number of subjects analysed
    37
    32
    33
    Units: millimeter(s)
        arithmetic mean (standard deviation)
    38.89 ( 29.80 )
    37.47 ( 28.09 )
    20.97 ( 23.27 )
    Statistical analysis title
    		 Primary Endpoint
    Comparison groups
    BMV plaster 24h v BMV plaster 12h v PBO plaster
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were evaluated at each visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    BMV plaster 24h
    Reporting group description
    		 -

    Reporting group title
    BMV plaster 12h
    Reporting group description
    		 -

    Reporting group title
    PBO plaster
    Reporting group description
    		 -

    Serious adverse events
    		 BMV plaster 24h BMV plaster 12h PBO plaster
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Transverse sinus thrombosis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BMV plaster 24h BMV plaster 12h PBO plaster
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 37 (24.32%)
    5 / 32 (15.63%)
    11 / 33 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 37 (10.81%)
    2 / 32 (6.25%)
    5 / 33 (15.15%)
         occurrences all number
    4
    2
    5
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Application site oedema
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0

    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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