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    Clinical Trial Results:
    Randomised, double blind, parallel-groups, non-inferiority versus Flector® and superiority versus Placebo, Phase III clinical trial with Diclofenac Sodium 140 mg medicated plaster in patients with impact injuries of the limbs

    Summary
    EudraCT number
    		 2017-003526-32
    Trial protocol
    		 DE   HU   IT  
    Global end of trial date
    27 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2021
    First version publication date
    16 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EQI7-16-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fidia Farmaceutici S.p.A
    Sponsor organisation address
    via Ponte della Fabbrica, Abano Terrme, Italy, 35031
    Public contact
    Flavia Baruzzi, LB Research S.r.l., 0039 031734908, ngiordan@fidiapharma.it
    Scientific contact
    Flavia Baruzzi, LB Research S.r.l., 3351042048 031734908, ngiordan@fidiapharma.it
    Sponsor organisation name
    Fidia Farmaceutici S.p.A
    Sponsor organisation address
    via Ponte della Fabbrica, Abano Terrme, Italy, 35031
    Public contact
    Giordan Nicola , Fidia Farmaceutici S.p.A, 0039 0498232512, ngiordan@fidiapharma.it
    Scientific contact
    Giordan Nicola , Fidia Farmaceutici S.p.A, 0039 0498232512, ngiordan@fidiapharma.it
    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
    27 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to show non-inferior efficacy of Test Diclofenac Sodium 140 mg medicated plaster (once a day) over a Reference Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector® (once a day), and that both Test and Reference are superior to Placebo plaster (once a day) in improving pain at rest at 72 ± 2 hours (Day 4) after treatment start in patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs. A 100-mm Visual Analogue Scale (VAS) will be used for the assessment of pain at rest.
    Protection of trial subjects
    Female of child-bearing potential (i.e. not in menopausal status from at least one year or permanently sterilized) had to have a negative urine pregnancy test prior the first investigational medicinal product (IMP) administration
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2018
    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: 44
    Country: Number of subjects enrolled
    Hungary: 165
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    214
    EEA total number of subjects
    214
    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)
    207
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 214
    Number of subjects completed
    		 214

    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, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test Diclofenac Sodium 140 mg medicated plaster
    Arm description
    		 Test Diclofenac Sodium 140 mg medicated plaster
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diclofenac Sodium 140 mg medicated plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical
    Dosage and administration details
    T0 mg medicated plaster once a day

    Arm title
    		 DIEP 180 mg medicated plaster
    Arm description
    		 DIEP 180 mg medicated plaster
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DIEP 180 mg medicated plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical
    Dosage and administration details
    DIEP 180 mg medicated plaster once a day

    Investigational medicinal product name
    Placebo Plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical
    Dosage and administration details
    Placebo Plaster once a day

    Arm title
    		 Placebo Plaster
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical
    Dosage and administration details
    Placebo plaster once a day

    Number of subjects in period 1
    		Test Diclofenac Sodium 140 mg medicated plaster DIEP 180 mg medicated plaster Placebo Plaster
    Started
    71
    72
    71
    Completed
    71
    72
    71

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Test Diclofenac Sodium 140 mg medicated plaster
    Reporting group description
    		 Test Diclofenac Sodium 140 mg medicated plaster

    Reporting group title
    DIEP 180 mg medicated plaster
    Reporting group description
    		 DIEP 180 mg medicated plaster

    Reporting group title
    Placebo Plaster
    Reporting group description
    		 -

    Subject analysis set title
    IIT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Intention-to-treat (ITT) population, which included all randomized patients who took at least one plaster of study medication and had at least one post-baseline assessment of efficacy

    Primary: change from baseline in VAS score for pain at rest at 72 ± 2 hours (Day 4) after treatment start

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    End point title
    		 change from baseline in VAS score for pain at rest at 72 ± 2 hours (Day 4) after treatment start
    End point description
    End point type
    Primary
    End point timeframe
    change from baseline at 72 ± 2 hours (Day 4) after treatment start
    End point values
    		 Test Diclofenac Sodium 140 mg medicated plaster DIEP 180 mg medicated plaster Placebo Plaster IIT
    Number of subjects analysed
    71
    72
    71
    214
    Units: mm
        arithmetic mean (standard deviation)
    -18.2 ± 17
    -17.1 ± 14.7
    -11.4 ± 14
    -18.2 ± 17
    Statistical analysis title
    		 mixed linear model with change from baseline to Da
    Comparison groups
    Test Diclofenac Sodium 140 mg medicated plaster v DIEP 180 mg medicated plaster v Placebo Plaster v IIT
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.05
    Method
    		 mixed linear model
    Confidence interval
    Notes
    [1] - The analysis of non-inferiority of Test (Diclofenac sodium 140 mg once a day) versus Reference (DIEP 180 mg once a day) on primary endpoint change from baseline in VAS score for pain at rest at 72 ± 2 hours (Day 4) was carried-out using a mixed linear model with change from baseline to Day 4 as dependent variable, treatment group and site as fixed factors of the model, baseline VAS for pain at rest as covariate and patient as random effect.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the first dose of study medication until the end of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Diclofenac Sodium 140 mg medicated plaster
    Reporting group description
    		 -

    Serious adverse events
    		 Diclofenac Sodium 140 mg medicated plaster
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 71 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Diclofenac Sodium 140 mg medicated plaster
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 71 (7.04%)
    Nervous system disorders
    Hypoesthesia
         subjects affected / exposed
    2 / 71 (2.82%)
         occurrences all number
    3
    Paresthesia
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 71 (4.23%)
         occurrences all number
    5
    Skin burning sensation
         subjects affected / exposed
    3 / 71 (4.23%)
         occurrences all number
    5

    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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