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    Clinical Trial Results:
    An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with painful diabetic neuropathy.

    Summary
    EudraCT number
    		 2012-000400-14
    Trial protocol
    		 ES   RO  
    Global end of trial date
    04 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ESTEVE-SIGM-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios Dr. Esteve. S.A. (ESTEVE)
    Sponsor organisation address
    Avda. Mare de Déu de Montserrat, 221., Barcelona, Spain, 08041
    Public contact
    Study Medical Monitor, Laboratorios del Dr. Esteve, +34 934466000, jcebrecos@esteve.es
    Scientific contact
    Study Medical Monitor, Laboratorios del Dr. Esteve, +34 934466000, jcebrecos@esteve.es
    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
    04 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 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 assess the analgesic efficacy of E-52862 in subjects with moderate to severe painful diabetic neuropathy.
    Protection of trial subjects
    The study will be conducted in compliance with the protocol, regulatory requirements, good clinical practice (GCP) and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 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
    Romania: 133
    Country: Number of subjects enrolled
    Spain: 30
    Worldwide total number of subjects
    163
    EEA total number of subjects
    163
    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)
    115
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in Spain and Romania, during 30-Oct-2012 (FSFV) and 4-Dec-2014 (LSLV)

    Pre-assignment
    Screening details
    		 Male and female patients ≥ 18 years, with pain due to polyneuropathy caused by DM 1 or DM 2, HbA1c ≤ 10.0%. Pain present for ≥ 6 months, but < 5 years, score ≥ 3 on the Michigan Neuropathy Screening Instrument, with a moderate to severe pain intensity measured by a score of ≥ 4 on the NPRS

    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, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E-52862
    Arm description
    		 Active arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    E-52862
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg once a day

    Arm title
    		 Control
    Arm description
    		 Control arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of placebo once a day

    Number of subjects in period 1
    		E-52862 Control
    Started
    85
    78
    Completed
    83
    77
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial (overall period) Total
    Number of subjects
    		 163 163
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    		 84 84
        Male
    		 79 79
    Subject analysis sets

    Subject analysis set title
    Per Protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who are deemed to have no major protocol violations that could interfere with the objectives of this study.

    Subject analysis sets values
    		 Per Protocol analysis set
    Number of subjects
    125
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.7 ± 8.55
    Gender categorical
    Units: Subjects
        Female
    72
        Male
    53

    End points

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    End points reporting groups
    Reporting group title
    E-52862
    Reporting group description
    		 Active arm

    Reporting group title
    Control
    Reporting group description
    		 Control arm

    Subject analysis set title
    Per Protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who are deemed to have no major protocol violations that could interfere with the objectives of this study.

    Primary: NPRS – Average pain – change from baseline to day 28

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    End point title
    		 NPRS – Average pain – change from baseline to day 28
    End point description
    End point type
    Primary
    End point timeframe
    Time specific change from baseline to day 28 in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS), included in a patient diary (average 24 hour pain)
    End point values
    		 E-52862 Control Per Protocol analysis set
    Number of subjects analysed
    61
    64
    125
    Units: numeric (pain rating scale)
        arithmetic mean (standard deviation)
    -2.6 ± 1.76
    -2.4 ± 1.83
    -2.5 ± 1.79
    Statistical analysis title
    		 Two-way ANCOVA model
    Statistical analysis description
    Analysis of variance (ANOVA) model including factors for treatment, center (fixed effects) and baseline value (covariate).
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6815
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.125
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.729
         upper limit
    		 0.478

    Secondary: NPRS – Worst pain – change from baseline to day 28

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    End point title
    		 NPRS – Worst pain – change from baseline to day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Time specific change from baseline to day 28 in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS), included in a patient diary (worst 24 hour pain)
    End point values
    		 E-52862 Control Per Protocol analysis set
    Number of subjects analysed
    61
    64
    125
    Units: numeric (pain rating scale)
        arithmetic mean (standard deviation)
    -2.6 ± 1.76
    -2.8 ± 1.96
    -2.7 ± 1.86
    Statistical analysis title
    		 Two-way ANCOVA model
    Statistical analysis description
    Analysis of variance (ANOVA) model including factors for treatment, center (fixed effects) and baseline value (covariate).
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5125
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.213
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.857

    Secondary: 50% responders rate

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    End point title
    		 50% responders rate
    End point description
    End point type
    Secondary
    End point timeframe
    Reduction from baseline to day 28 of at least 50% of the 24-hour average pain score (measured by an NPRS included in the patient diary)
    End point values
    		 E-52862 Control
    Number of subjects analysed
    61
    64
    Units: percent
    number (not applicable)
        Responder
    44.3
    39.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first IMP intake up to two weeks after the last IMP administration
    Adverse event reporting additional description
    Treatment Emergent Adverse Event are displayed. The AEs that occurred after the first IMP intake are going to be considered as treatment emergent AEs (TEAEs) either serious or not.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    E-52862
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 E-52862 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 78 (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: 5%
    Non-serious adverse events
    		 E-52862 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 85 (34.12%)
    21 / 78 (26.92%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 85 (8.24%)
    5 / 78 (6.41%)
         occurrences all number
    16
    10
    Headache
         subjects affected / exposed
    3 / 85 (3.53%)
    5 / 78 (6.41%)
         occurrences all number
    4
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 85 (9.41%)
    0 / 78 (0.00%)
         occurrences all number
    15
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 85 (0.00%)
    5 / 78 (6.41%)
         occurrences all number
    0
    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.
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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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