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    Clinical Trial Results:
    Comparison of the Efficacy of Diclofenac Sodium Topical Gel, 1% (Mylan) to Voltaren® Gel, 1% (Novartis US) and Placebo in Adult Subjects with Knee Osteoarthritis

    Summary
    EudraCT number
    		 2012-002682-36
    Trial protocol
    		 HU  
    Global end of trial date
    30 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2020
    First version publication date
    06 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DGEL-12058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mylan Pharmaceuticals Inc
    Sponsor organisation address
    3711, Collins Ferry Road, Morgantown, United States,
    Public contact
    Clinical Trial Information Desk, Mylan Pharmaceuticals Inc, 001 304554-6693,
    Scientific contact
    Clinical Trial Information Desk, Mylan Pharmaceuticals Inc, 001 304554-6693,
    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
    06 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to investigate the clinical endpoint bioequivalence of Mylan's Diclofenac Sodium Topical Gel, 1% compared to Novartis US’ Voltaren® Gel, 1% and placebo (vehicle, Mylan) following multiple topical applications of 4 g to a single osteoarthritic knee (4 g four times daily for 4 weeks).
    Protection of trial subjects
    Study had a placebo control arm. Study allowed rescue medication use. Rescue medication was also allowed for the treatment of aches and pains unrelated to knee pain.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    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
    Ukraine: 66
    Country: Number of subjects enrolled
    Romania: 145
    Country: Number of subjects enrolled
    Poland: 763
    Country: Number of subjects enrolled
    Hungary: 288
    Worldwide total number of subjects
    1262
    EEA total number of subjects
    1196
    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)
    756
    From 65 to 84 years
    504
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After eligibility assessment at screening, patients were requested to discontinue their current OA therapy for a period of at least 7 days (or >5 half lives of the current therapy). Rescue medication was provided during this period and were requested to temporarily withdraw rescue medication use 24 hours prior to assessment visits

    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, Assessor
    Blinding implementation details
    The packaging of test, reference, and placebo investigational products was similar in appearance to make difference in treatment less obvious to the subjects and to maintain adequate blinding of evaluators.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test
    Arm description
    		 Test diclofenac sodium topical gel 1% (Mylan)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diclofenac sodium topical gel 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    4 g four times daily for 4 weeks).

    Arm title
    		 Reference
    Arm description
    		 Voltaren Gel 1%
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Voltaren® Gel 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    4 g four times daily for 4 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo gel
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    4 g four times daily for 4 weeks

    Number of subjects in period 1 [1]
    		Test Reference Placebo
    Started
    421
    417
    418
    Completed
    390
    392
    393
    Not completed
    31
    25
    25
         Adverse event, serious fatal
    -
    2
    -
         Consent withdrawn by subject
    7
    6
    5
         Other event
    2
    -
    -
         Adverse event, non-fatal
    7
    4
    5
         Lost to follow-up
    3
    1
    1
         Lack of efficacy
    2
    2
    2
         Protocol deviation
    10
    10
    12
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There were 6 patients (0 in Test Arm, 2 in Reference arm and 4 in Placeo arm) who were randomized but did not receive treatment. The reasons are not readily available in the CSR. These patients were not part of the safety population set. All tables and data analysis in the CSR are based on safety population and hence there is a discrepancy in total enrolled and the baseline numbers.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Test diclofenac sodium topical gel 1% (Mylan)

    Reporting group title
    Reference
    Reporting group description
    		 Voltaren Gel 1%

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo gel

    Reporting group values
    		 Test Reference Placebo Total
    Number of subjects
    		 421 417 418 1256
    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)
    		 260 251 241 752
        From 65-84 years
    		 161 165 176 502
        85 years and over
    		 0 1 1 2
    Gender categorical
    Units: Subjects
        Female
    		 327 318 315 960
        Male
    		 94 99 103 296
    Baseline VAS
    Baseline VAS
    Units: mm
        arithmetic mean (standard deviation)
    		 74.7 ± 11.7 74.6 ± 12.1 74.2 ± 11.6 -

    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Test diclofenac sodium topical gel 1% (Mylan)

    Reporting group title
    Reference
    Reporting group description
    		 Voltaren Gel 1%

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo gel

    Primary: Mean change from baseline to Week 4 in WOMAC pain score

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    End point title
    		 Mean change from baseline to Week 4 in WOMAC pain score
    End point description
    End point type
    Primary
    End point timeframe
    Week 4
    End point values
    		 Test Reference Placebo
    Number of subjects analysed
    400 [1]
    395 [2]
    398 [3]
    Units: Units
        least squares mean (standard error)
    -6.41 ± 0.20
    -6.64 ± 0.20
    -6.38 ± 0.20
    Notes
    [1] - mITT
    [2] - mITT
    [3] - mITT
    Statistical analysis title
    		 Therapeutic Equivalence between Test and Reference
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    795
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 LS Means Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.908
         upper limit
    		 1.032

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 4
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Test diclofenac sodium topical gel 1% (Mylan)

    Reporting group title
    Reference
    Reporting group description
    		 Voltaren Gel 1%

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo gel

    Serious adverse events
    		 Test Reference Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    2 / 418 (0.48%)
         number of deaths (all causes)
    0
    0
    2
         number of deaths resulting from adverse events
    0
    0
    2
    Nervous system disorders
    Meningitis bacterial
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 418 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 418 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Test Reference Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    158 / 421 (37.53%)
    154 / 417 (36.93%)
    152 / 418 (36.36%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    93 / 421 (22.09%)
    89 / 417 (21.34%)
    94 / 418 (22.49%)
         occurrences all number
    251
    243
    220
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    35 / 421 (8.31%)
    40 / 417 (9.59%)
    28 / 418 (6.70%)
         occurrences all number
    63
    82
    66
    Back pain
         subjects affected / exposed
    21 / 421 (4.99%)
    14 / 417 (3.36%)
    16 / 418 (3.83%)
         occurrences all number
    47
    29
    33
    Spinal pain
         subjects affected / exposed
    16 / 421 (3.80%)
    16 / 417 (3.84%)
    20 / 418 (4.78%)
         occurrences all number
    28
    28
    42
    Pain in extremity
         subjects affected / exposed
    10 / 421 (2.38%)
    18 / 417 (4.32%)
    14 / 418 (3.35%)
         occurrences all number
    24
    30
    28
    Musculoskeletal pain
         subjects affected / exposed
    8 / 421 (1.90%)
    6 / 417 (1.44%)
    9 / 418 (2.15%)
         occurrences all number
    19
    10
    12

    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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