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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, as part of an analgesic therapy balanced with morphine, followed by an open label extension, in the treatment of post-operative pain due to abdominal hysterectomy

    Summary
    EudraCT number
    		 2011-003302-24
    Trial protocol
    		 ES  
    Global end of trial date
    26 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2016
    First version publication date
    03 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ESTEVE-SIGM-201
    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
    Jesus Cebrecos, Laboratorios Dr. Esteve S.A., 34 934466000, jcebrecos@esteve.es
    Scientific contact
    Jesus Cebrecos, Laboratorios Dr. Esteve S.A., 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
    31 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2013
    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 effect of E-52862 compared to placebo on pain following hysterectomy, measured through the morphine consumption administered by Patient Controlled Analgesia (PCA) during the first 24 post-operative hours, pain at rest and movement-evoked pain.
    Protection of trial subjects
    The study has been 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
    13 Feb 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 121
    Worldwide total number of subjects
    121
    EEA total number of subjects
    121
    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)
    121
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in Spain, during 13-Feb-2012 ( FSFV) and 26-Sep-2013 (LSLV)

    Pre-assignment
    Screening details
    		 Female patients aged between 18 and 80 years, scheduled for an elective non-malignant partial or total abdominal hysterectomy (non laparoscopic) under general anaesthesia (patients with cervix carcinoma stage 1 or endometrial carcinoma stage 1 can be also included)

    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
    		 400 mg once a day , during three days.
    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
    		 1 capsule of placebo once a day , during three days.
    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
    60
    61
    Completed
    52
    52
    Not completed
    8
    9
         Adverse event, non-fatal
    1
    1
         Suspended surgery
    2
    2
         Prohibited Medication
    5
    6

    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
    		 121 121
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 121 121
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.02 ( 5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 121 121
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who receive at least 1 dose of the study drug. Safety analysis will be performed on the safety set.

    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
    		 Safety analysis set Per Protocol analysis set
    Number of subjects
    121
    104
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    121
    104
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.02 ( 5 )
    46.19 ( 4.95 )
    Gender categorical
    Units: Subjects
        Female
    121
    104

    End points

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    End points reporting groups
    Reporting group title
    E-52862
    Reporting group description
    		 400 mg once a day , during three days.

    Reporting group title
    Control
    Reporting group description
    		 1 capsule of placebo once a day , during three days.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who receive at least 1 dose of the study drug. Safety analysis will be performed on the safety set.

    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: Total morphine consumption administered by PCA (24 hours)

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    End point title
    		 Total morphine consumption administered by PCA (24 hours)
    End point description
    Total morphine consumption in mg administered by PCA during the 24 hours post-operative period.
    End point type
    Primary
    End point timeframe
    24 hours post-operative period.
    End point values
    		 E-52862 Control Per Protocol analysis set
    Number of subjects analysed
    52
    52
    104
    Units: mg
        arithmetic mean (standard deviation)
    27.14 ( 17.57 )
    24.43 ( 14.22 )
    25.79 ( 15.96 )
    Statistical analysis title
    		 Two-way ANOVA model
    Statistical analysis description
    Two-way ANOVA model with treatment and centre as factors.
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3892
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.45
         upper limit
    		 3.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.96

    Secondary: Total morphine consumption administered by PCA (48 hours)

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    End point title
    		 Total morphine consumption administered by PCA (48 hours)
    End point description
    Total morphine consumption in mg administered by PCA during the 48 hours post-operative period.
    End point type
    Secondary
    End point timeframe
    48 hours post-operative period.
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: mg
        arithmetic mean (standard deviation)
    38.42 ( 22.27 )
    35.11 ( 18.89 )
    Statistical analysis title
    		 Two- way ANOVA model
    Statistical analysis description
    Two-way ANOVA model with treatment and center as factors.
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.437
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.93
         upper limit
    		 4.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.95

    Secondary: Total morphine consumption PCA plus subcutaneous (24h)

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    End point title
    		 Total morphine consumption PCA plus subcutaneous (24h)
    End point description
    Total morphine consumption in mg administered by PCA plus subcutaneous injection during the 24 hours post-operative period.
    End point type
    Secondary
    End point timeframe
    24 hours post-operative period.
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: mg
        arithmetic mean (standard deviation)
    28.47 ( 18.55 )
    25.91 ( 14.97 )
    Statistical analysis title
    		 Two-way ANOVA model
    Statistical analysis description
    two-way ANOVA model with treatment and center as factors.
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4738
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.35
         upper limit
    		 3.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.09

    Secondary: Total morphine consumption PCA plus subcutaneous (48h)

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    End point title
    		 Total morphine consumption PCA plus subcutaneous (48h)
    End point description
    Total morphine consumption in mg administered by PCA plus subcutaneous injection during the 48 hours post-operative period.
    End point type
    Secondary
    End point timeframe
    48 hours post-operative period
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: mg
        arithmetic mean (standard deviation)
    40.45 ( 23.64 )
    36.58 ( 19.5 )
    Statistical analysis title
    		 Two-way ANOVA model
    Statistical analysis description
    Two-way ANOVA model with treatment and center as factors
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.399
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.58
         upper limit
    		 4.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.09

    Secondary: Pain intensity at rest (8h)

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    End point title
    		 Pain intensity at rest (8h)
    End point description
    Pain intensity at rest during the first 8 hours after the end of surgery.
    End point type
    Secondary
    End point timeframe
    8 hours after the end of surgery.
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: cm
        arithmetic mean (standard deviation)
    1.73 ( 1.58 )
    2.11 ( 1.54 )
    Statistical analysis title
    		 ANOVA repeated measures mixed model
    Statistical analysis description
    ANOVA repeated measures mixed model, with terms for treatment, time, site and interaction between treatment and time as fixed effects and subject as a random effect.
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0465
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.15
         upper limit
    		 -0.0092
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29

    Secondary: Pain intensity at rest (18h)

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    End point title
    		 Pain intensity at rest (18h)
    End point description
    Pain intensity at rest during the first 18 hours after the end of surgery.
    End point type
    Secondary
    End point timeframe
    18 hours after the end of surgery
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: cm
        arithmetic mean (standard deviation)
    1.5 ( 1.52 )
    1.85 ( 1.97 )
    Statistical analysis title
    		 ANOVA repeated measures mixed model.
    Statistical analysis description
    ANOVA repeated measures mixed model, with terms for treatment, time, site and interaction between treatment and time as fixed effects and subject as a random effect.
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0469
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 -0.0074
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27

    Secondary: Pain intensity at rest (24h)

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    End point title
    		 Pain intensity at rest (24h)
    End point description
    Pain intensity at rest during the first 24 hours after the end of surgery.
    End point type
    Secondary
    End point timeframe
    24 hours after the end of surgery.
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: cm
        arithmetic mean (standard deviation)
    1.6 ( 1.61 )
    1.6 ( 1.64 )
    Statistical analysis title
    		 ANOVA repeated measures mixed model.
    Statistical analysis description
    ANOVA repeated measures mixed model, with terms for treatment, time, site and interaction between treatment and time as fixed effects and subject as a random effect.
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0588
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 0.018
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25

    Secondary: Consumption of pain rescue medication

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    End point title
    		 Consumption of pain rescue medication
    End point description
    Percentage of patients that required pain rescue medication during the first 48 hours after the end of surgery.
    End point type
    Secondary
    End point timeframe
    First 48 hours after the end of surgery.
    End point values
    		 E-52862 Control
    Number of subjects analysed
    52
    52
    Units: Patients
        Rescue Medication
    16
    15
        No Rescue Medication
    36
    37
    Statistical analysis title
    		 Chi Square test
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8303
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Long term assessment of post-operative pain

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    End point title
    		 Long term assessment of post-operative pain
    End point description
    Long term assessment of post-operative pain: incidence of pain at 6 months
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 E-52862 Control
    Number of subjects analysed
    53
    47
    Units: Patients
        Pain
    8
    7
        No Pain
    45
    40
    Statistical analysis title
    		 Fisher exact test
    Comparison groups
    E-52862 v Control
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    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).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    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
    7 / 60 (11.67%)
    4 / 61 (6.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Anaemia postoperative
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Shock
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervix haematoma uterine
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haematoma
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic haematoma
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal wall haematoma
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
    Additional description: This Adverse Event was considered non- related to study medication but related to the surgical procedure itself.
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    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
    41 / 60 (68.33%)
    44 / 61 (72.13%)
    Nervous system disorders
    Headache
    Additional description: 0 out of 9 were assessed as related to E-52862 and 0 out of 5 were assessed as related to placebo.
         subjects affected / exposed
    8 / 60 (13.33%)
    5 / 61 (8.20%)
         occurrences all number
    9
    5
    Dizziness
    Additional description: 1 out of 3 were assessed as related to E-52862 and 0 out of 8 were assessed as related to placebo.
         subjects affected / exposed
    3 / 60 (5.00%)
    7 / 61 (11.48%)
         occurrences all number
    3
    8
    Gastrointestinal disorders
    Nausea
    Additional description: 4 out of 19 were assessed as related to E-52862 and 7 out of 26 were assessed as related to placebo.
         subjects affected / exposed
    14 / 60 (23.33%)
    23 / 61 (37.70%)
         occurrences all number
    19
    26
    Vomiting
    Additional description: 2 out of 3 were assessed as related to E-52862 and 3 out of 10 were assessed as related to placebo.
         subjects affected / exposed
    3 / 60 (5.00%)
    9 / 61 (14.75%)
         occurrences all number
    3
    10
    Constipation
    Additional description: 1 out of 3 were assessed as related to E-52862 and 0 out of 1 were assessed as related to placebo.
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 61 (1.64%)
         occurrences all number
    3
    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.
    Strictly Confidential Information and Data. Property of ESTEVE
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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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