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    Clinical Trial Results:
    Efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women: The GaPP2 RCT

    Summary
    EudraCT number
    2014-005035-13
    Trial protocol
    GB  
    Global end of trial date
    13 Nov 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    31 Mar 2021
    First version publication date
    31 Mar 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    GaPP2
    Additional study identifiers
    ISRCTN number
    ISRCTN77451762
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Edinburgh
    Sponsor organisation address
    Little France Crescent, Edinburgh, United Kingdom, EH16 4SA
    Public contact
    Ann Doust, University of Edinburgh, 0044 1312429492, ann.doust@ed.ac.uk
    Scientific contact
    Ann Doust, University of Edinburgh, 0044 1312429492, ann.doust@ed.ac.uk
    Sponsor organisation name
    NHS Lothian
    Sponsor organisation address
    Little France Crescent, Edinburgh, United Kingdom, EH16 4SA
    Public contact
    Ann Doust, NHS Lothian, 0044 1312429492, ann.doust@ed.ac.uk
    Scientific contact
    Ann Doust, NHS Lothian, 0044 1312429492, ann.doust@ed.ac.uk
    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
    13 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test if women with chronic pelvic pain (where no cause for their pain has been found) can be safely treated with gabapentin to gain good pain relief.
    Protection of trial subjects
    A Data Monitoring Committee was appointed and met six times throughout the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 306
    Worldwide total number of subjects
    306
    EEA total number of subjects
    306
    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)
    306
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    We recruited 306 women over a period from November 2015 to March 2019. Participants were recruited from 39 UK hospital centres.

    Pre-assignment
    Screening details
    Participants were referred to the research team by their clinical team. Participants entered a screening phase where they were required to return their worst and average pain scores on a numerical scale weekly for four weeks. At least two of the worst NRS pain scores needed to be ≥4 in order for their pain to be considered sufficient for trial.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg starting dose titrated up to 2700mg daily over four weeks (placebo dose equivalent). Maximum tolerated dose maintained for 12 weeks.

    Arm title
    Active
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Gabapentin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg starting dose titrated up to 2700mg daily over four weeks. Maximum tolerated dose maintained for 12 weeks.

    Number of subjects in period 1
    Placebo Active
    Started
    153
    153
    Completed
    153
    153
    Period 2
    Period 2 title
    End of study
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg starting dose titrated up to 2700mg daily over four weeks (placebo dose equivalent). Maximum tolerated dose maintained for 12 weeks.

    Arm title
    Active
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Gabapentin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg starting dose titrated up to 2700mg daily over four weeks. Maximum tolerated dose maintained for 12 weeks.

    Number of subjects in period 2
    Placebo Active
    Started
    153
    153
    Completed
    153
    153

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Active
    Reporting group description
    -

    Reporting group values
    Placebo Active Total
    Number of subjects
    153 153 306
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    153 153 306
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    30.1 ± 8.6 30.5 ± 7.7 -
    Gender categorical
    Units: Subjects
        Female
    153 153 306
        Male
    0 0 0
    Education
    Units: Subjects
        Primary
    5 4 9
        Secondary
    46 47 93
        Tertiary
    101 101 202
        Missing
    1 1 2
    Dysmenorrhoea
    Units: Subjects
        Yes
    100 100 200
        No
    53 53 106
    Menstruating
    Units: Subjects
        Yes
    108 109 217
        No
    45 44 89
    Current use of sex hormones
    Units: Subjects
        Yes
    99 99 198
        No
    54 54 108
    Ethnicity
    Units: Subjects
        White
    148 150 298
        Black (Carribean/African/Other)
    0 1 1
        Asian (Indian/Pakistani/Bangladeshi/Other)
    4 2 6
        Mixed (Carribean/African/Asian/Other)
    1 0 1
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.8 ± 5.9 27.1 ± 5.7 -
    PUF Symptom Score
    Units: Score
        arithmetic mean (standard deviation)
    10.0 ± 4.5 9.7 ± 4.1 -
    PUF bother score
    Units: score
        arithmetic mean (standard deviation)
    5.4 ± 2.8 5.3 ± 2.6 -
    PUF total score
    Units: score
        arithmetic mean (standard deviation)
    15.5 ± 7.0 15.0 ± 6.3 -
    GHQ Score
    Units: Score
        arithmetic mean (standard deviation)
    4.7 ± 3.7 4.6 ± 3.7 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Active
    Reporting group description
    -
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Active
    Reporting group description
    -

    Primary: End of study Worst NRS pain score

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    End point title
    End of study Worst NRS pain score
    End point description
    End point type
    Primary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    122
    124
    Units: Score
    arithmetic mean (standard deviation)
        Worst NRS pain score
    7.4 ± 2.2
    7.1 ± 2.6
    Statistical analysis title
    Statistical analysis
    Statistical analysis description
    End of study Worst NRS pain score
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.47
    Method
    Regression, Linear
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -0.81
         upper limit
    0.42

    Primary: End of study Average NRS pain score

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    End point title
    End of study Average NRS pain score
    End point description
    End point type
    Primary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    121
    123
    Units: Score
    arithmetic mean (standard deviation)
        Average NRS pain score
    4.5 ± 2.2
    4.3 ± 2.3
    Statistical analysis title
    Statistical analysis
    Statistical analysis description
    End of study Average NRS pain score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.45
    Method
    Regression, Linear
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.18
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -0.71
         upper limit
    0.35

    Secondary: End of study SF-12 mental component score

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    End point title
    End of study SF-12 mental component score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    110
    111
    Units: Score
    arithmetic mean (standard deviation)
        End of study SF-12 mental component
    42.5 ± 11.1
    41.3 ± 10.6
    Statistical analysis title
    End of study -SF36 Mental Component Score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.11
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -4.6
         upper limit
    2.39

    Secondary: End of study SF-12 physical component score

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    End point title
    End of study SF-12 physical component score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    110
    111
    Units: Score
    arithmetic mean (standard deviation)
        End of study SF-12 physical component
    44.6 ± 10.1
    43.8 ± 10.6
    Statistical analysis title
    End of study -SF36 Physical Component Score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.49
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -2.27
         upper limit
    3.24

    Secondary: End of study BPI pain interference score

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    End point title
    End of study BPI pain interference score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    112
    111
    Units: Score
    arithmetic mean (standard deviation)
        End of study BPI pain interference
    3.6 ± 2.8
    3.6 ± 2.8
    Statistical analysis title
    End of study-BPI Pain Interference score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -0.84
         upper limit
    0.77

    Secondary: End of study BFI global fatigue score

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    End point title
    End of study BFI global fatigue score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    112
    111
    Units: Score
    arithmetic mean (standard deviation)
        End of study BFI global fatigue
    4.0 ± 2.7
    4.2 ± 2.5
    Statistical analysis title
    End of study-BFI Global Fatigue score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -0.65
         upper limit
    0.89

    Secondary: End of study GHQ score

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    End point title
    End of study GHQ score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    111
    111
    Units: Score
        arithmetic mean (standard deviation)
    3.0 ± 3.5
    3.8 ± 3.9
    Statistical analysis title
    Statistical analysis
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.72
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -0.49
         upper limit
    1.94

    Secondary: End of study WPAIQ activity impairment score

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    End point title
    End of study WPAIQ activity impairment score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    111
    110
    Units: Score
    arithmetic mean (standard deviation)
        End of study WPAIQ activity impairment
    38.6 ± 29.6
    39.3 ± 29.0
    Statistical analysis title
    Statistical analysis
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.77
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -9.66
         upper limit
    8.12

    Secondary: End of study PCQ sore

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    End point title
    End of study PCQ sore
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    111
    111
    Units: Score
        arithmetic mean (standard deviation)
    19.7 ± 12.5
    20.8 ± 14.6
    Statistical analysis title
    End of Study PCQ Score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.48
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -3.24
         upper limit
    4.2

    Secondary: End of study SAQ pleasure score

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    End point title
    End of study SAQ pleasure score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    69
    83
    Units: Score
        arithmetic mean (standard deviation)
    10.9 ± 4.1
    10.8 ± 4.5
    Statistical analysis title
    End of study -SAQ Pleasure Score
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -1.84
         upper limit
    1.56

    Secondary: End of study SAQ discomfort score

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    End point title
    End of study SAQ discomfort score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    68
    84
    Units: Score
        arithmetic mean (standard deviation)
    3.3 ± 2.0
    3.6 ± 1.9
    Statistical analysis title
    End of study-SAQ Discomfort score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.17
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -0.55
         upper limit
    0.9

    Secondary: End of study SAQ habit score

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    End point title
    End of study SAQ habit score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    69
    83
    Units: Score
        arithmetic mean (standard deviation)
    0.9 ± 0.7
    1.1 ± 0.8
    Statistical analysis title
    End of study -SAQ habit Score
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.19
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -0.15
         upper limit
    0.53

    Secondary: End of study PainDETECT score

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    End point title
    End of study PainDETECT score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    107
    111
    Units: Score
        arithmetic mean (standard deviation)
    10.9 ± 6.7
    12.4 ± 6.8
    Statistical analysis title
    End of study -PainDETECT Score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.19
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -0.74
         upper limit
    3.12

    Secondary: 30% reduction in worst NRS scores

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    End point title
    30% reduction in worst NRS scores
    End point description
    30% reduction in worst NRS scores from baseline.
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    122
    124
    Units: number
        >=30% reduction
    21
    30
        <30% reduction
    101
    94
    Statistical analysis title
    30% Reduction in worst NRS scores
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.38
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    2.64

    Secondary: 30% reduction in average NRS scores

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    End point title
    30% reduction in average NRS scores
    End point description
    30% reduction in average NRS scores from baseline
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    121
    123
    Units: number
        >=30%
    37
    44
        <30%
    84
    79
    Statistical analysis title
    30% Reduction in average NRS scores
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.12
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.8

    Secondary: 50% reduction in worst NRS scores

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    End point title
    50% reduction in worst NRS scores
    End point description
    50% reduction in worst NRS scores from baseline
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    122
    124
    Units: number
        >=50%
    10
    19
        <50%
    112
    105
    Statistical analysis title
    50% Reduction in worst NRS scores
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.84
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    4.75

    Secondary: 50% reduction in average NRS scores

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    End point title
    50% reduction in average NRS scores
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    121
    123
    Units: number
        >=50%
    19
    27
        <50%
    102
    96
    Statistical analysis title
    50% Reduction in average NRS scores
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.36
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    2.72

    Secondary: End of study WPAIQ Absenteeism score

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    End point title
    End of study WPAIQ Absenteeism score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    89
    83
    Units: score
        arithmetic mean (standard deviation)
    4.9 ± 15.1
    10.8 ± 23.5
    Statistical analysis title
    End of study-WPAIQ Absenteeism Score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.32
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -2.06
         upper limit
    12.71

    Secondary: End of study WPAIQ Presenteeism score

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    End point title
    End of study WPAIQ Presenteeism score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    79
    72
    Units: score
        arithmetic mean (standard deviation)
    38.0 ± 29.6
    36.4 ± 28.4
    Statistical analysis title
    End of study-WPAIQ Presenteeism Score
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.89
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -14.43
         upper limit
    10.65

    Secondary: End of study WPAIQ Productivity Loss score

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    End point title
    End of study WPAIQ Productivity Loss score
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    79
    72
    Units: score
        arithmetic mean (standard deviation)
    39.2 ± 30.7
    39.9 ± 31.1
    Statistical analysis title
    End of study-WPAIQ Productivity Loss Score
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.43
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    -13.73
         upper limit
    12.87

    Secondary: End of study-Number of healthcare visits for pelvic pain: GP

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    End point title
    End of study-Number of healthcare visits for pelvic pain: GP
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    109
    111
    Units: number
        None
    62
    62
        1 appt
    21
    16
        2 appts
    11
    16
        3+ appts
    15
    17
    No statistical analyses for this end point

    Secondary: End of study-Number of healthcare visits for pelvic pain: Hospital outpatients

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    End point title
    End of study-Number of healthcare visits for pelvic pain: Hospital outpatients
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    109
    111
    Units: number
        None
    83
    89
        1 appt
    20
    16
        2 appts
    4
    2
        3+ appts
    2
    4
    No statistical analyses for this end point

    Secondary: End of study-Number of healthcare visits for pelvic pain: Practice nurse

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    End point title
    End of study-Number of healthcare visits for pelvic pain: Practice nurse
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    109
    110
    Units: number
        None
    103
    99
        1 appt
    3
    8
        2 appts
    1
    1
        3+ appts
    2
    2
    No statistical analyses for this end point

    Secondary: End of study-Number of healthcare visits for pelvic pain: Physiotherapist

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    End point title
    End of study-Number of healthcare visits for pelvic pain: Physiotherapist
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    109
    110
    Units: number
        None
    105
    107
        1 appt
    0
    1
        2 appts
    1
    1
        3+ appts
    3
    1
    No statistical analyses for this end point

    Secondary: End of study-Number of healthcare visits for pelvic pain: Other

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    End point title
    End of study-Number of healthcare visits for pelvic pain: Other
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    Placebo Active
    Number of subjects analysed
    109
    110
    Units: number
        None
    97
    99
        1 appt
    5
    6
        2 appts
    3
    2
        3+ appts
    4
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of randomisation to end of study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Active arm
    Reporting group description
    -

    Reporting group title
    Placebo arm
    Reporting group description
    -

    Serious adverse events
    Active arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 153 (6.54%)
    3 / 153 (1.96%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Cardiac disorders
    Hypotension
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Scleritis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Cholecystitis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Paranoia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Perforated uterus
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst removal
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chest infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    Active arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    124 / 153 (81.05%)
    116 / 153 (75.82%)
    Vascular disorders
    Epistaxis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Sterilisation
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Mole excision
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Tonsillectomy
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Lumbar puncture normal
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 153 (0.00%)
         occurrences all number
    2
    0
    Cyst removal
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Cystoscopy
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergic respiratory symptom
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 153 (4.58%)
    1 / 153 (0.65%)
         occurrences all number
    8
    1
    Thirst
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    mental fogginess
         subjects affected / exposed
    4 / 153 (2.61%)
    0 / 153 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 153 (1.31%)
    1 / 153 (0.65%)
         occurrences all number
    2
    1
    Anxiety
         subjects affected / exposed
    2 / 153 (1.31%)
    1 / 153 (0.65%)
         occurrences all number
    3
    1
    Hallucination
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 153 (0.00%)
         occurrences all number
    2
    0
    Obsessive-compulsive symptom
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Hyperactive
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Bartholin's cyst
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Breast abscess
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Breast pain
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Menorrhagia
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 153 (0.00%)
    6 / 153 (3.92%)
         occurrences all number
    0
    6
    Vaginal discharge
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 153 (0.00%)
         occurrences all number
    2
    0
    Pelvic pain
         subjects affected / exposed
    6 / 153 (3.92%)
    3 / 153 (1.96%)
         occurrences all number
    6
    4
    Raised CA-125
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Contusion
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    2
    Electric shock
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Investigations
    Smear cervix abnormal
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Lymphoma possible
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    2 / 153 (1.31%)
    3 / 153 (1.96%)
         occurrences all number
    2
    3
    Palpitations
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 153 (1.96%)
    2 / 153 (1.31%)
         occurrences all number
    3
    2
    Asthma
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Wheezing
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 153 (3.92%)
    3 / 153 (1.96%)
         occurrences all number
    6
    3
    Headache
         subjects affected / exposed
    4 / 153 (2.61%)
    7 / 153 (4.58%)
         occurrences all number
    5
    10
    Loss of consciousness
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    4 / 153 (2.61%)
    4 / 153 (2.61%)
         occurrences all number
    4
    5
    Paresthesia
         subjects affected / exposed
    3 / 153 (1.96%)
    1 / 153 (0.65%)
         occurrences all number
    3
    1
    Sciatica
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Eye disorders
    Twitch
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Visual disturbances
         subjects affected / exposed
    3 / 153 (1.96%)
    2 / 153 (1.31%)
         occurrences all number
    3
    2
    Blistering of eye
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Epigastric discomfort
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Abdominal distension
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 153 (1.31%)
    4 / 153 (2.61%)
         occurrences all number
    3
    4
    Dry mouth
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 153 (0.00%)
         occurrences all number
    3
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 153 (0.65%)
    2 / 153 (1.31%)
         occurrences all number
    1
    2
    Abdominal discomfort
         subjects affected / exposed
    6 / 153 (3.92%)
    7 / 153 (4.58%)
         occurrences all number
    9
    8
    Tooth abscess
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 153 (1.31%)
    6 / 153 (3.92%)
         occurrences all number
    3
    6
    Nausea
         subjects affected / exposed
    0 / 153 (0.00%)
    6 / 153 (3.92%)
         occurrences all number
    0
    6
    Geographic tongue
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Incontinence
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Polyuria
         subjects affected / exposed
    2 / 153 (1.31%)
    3 / 153 (1.96%)
         occurrences all number
    2
    3
    Haematinuria
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Renal colic
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Facial spots
         subjects affected / exposed
    1 / 153 (0.65%)
    2 / 153 (1.31%)
         occurrences all number
    1
    2
    Itch
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 153 (1.96%)
    0 / 153 (0.00%)
         occurrences all number
    4
    0
    Pain
         subjects affected / exposed
    2 / 153 (1.31%)
    4 / 153 (2.61%)
         occurrences all number
    3
    5
    Intervertebral disc displacement
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc pseudobulging
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Ankle impingement
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Asthenia
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Loin pain
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Fracture
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 153 (0.00%)
         occurrences all number
    2
    0
    Folate deficiency
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 153 (0.00%)
         occurrences all number
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    Anaemia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    5 / 153 (3.27%)
    5 / 153 (3.27%)
         occurrences all number
    5
    5
    Chlamydial infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 153 (0.65%)
    4 / 153 (2.61%)
         occurrences all number
    1
    4
    Ear infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    5 / 153 (3.27%)
    1 / 153 (0.65%)
         occurrences all number
    5
    1
    Gingivitis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Wound infection
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 153 (0.65%)
    3 / 153 (1.96%)
         occurrences all number
    1
    3
    Candida infection
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Urinary tract infection
         subjects affected / exposed
    7 / 153 (4.58%)
    2 / 153 (1.31%)
         occurrences all number
    10
    2
    Viral infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Aug 2015
    1. We have included more details with regard to a number of the objectives and the criteria for entry to the trial. These are indicated in track changes within the protocol. 2. We have also added an additional embedded pharmacogenetic substudy to investigate the influence of genetic variation on gabapentin efficacy and potential intolerance, and the potential for stratification of patients with likely drug response based on genetic profiles.
    22 Feb 2016
    Insertion of ISCTRN and funding references Clarification of unblinding procedures Update of contact details Removal of analgesic use while in study details to reflect the analgesic use may reduce. This was written in error in the original protocol as we hope that analgesic use will decrease over the course of the study for some of the participants. Removal of heat stimulus from fMRI process. The thermal equipment was temperamental in the mock scans we ran and looking at the pilot data the pin pricks gave us the desired effect on the brain so it was felt that the thermal stimulus was unnecessary and prolonged the scanning process. Change of fMRI PIS to remove thermal stimuli Addition of pt emergency card - to identify participants in case of emergencies.
    14 Mar 2016
    Changes to the SmPC for gabapentin 300 mgs
    03 May 2016
    Amendment to emergency card
    28 Feb 2017
    Addition of a healthy volunteer are to the fMRI substudy. On monitoring the first patients at each site, certain deviations were noted. These were in the timing of visit 5. The last text pain score is collected at the end of week 16 and therefore unblinding cannot take place during this week so for clarity this has been changed to week 17. Participants increase and decrease their doses of gabapentin throughout the course of the trial which reflects real life situations and therefore these fluctuations will be captured but will not be seen as a deviation. The use of rescue analgesia will be restricted only by the SmPC and not by the protocol as these did not reflect common clinical practices. SmPC for gabapentin 300mgs has been updated. RSI information has changed. All sites notified of the change. The annual reporting period is coming to an end and therefore the SmPC can now be changed.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Dec 2017
    In December 2017, we had to stop randomising participants to treatment while we waited for the outcome of our costed extension request. In February 2018, we were informed that our costed extension had been granted. We instructed Sharp Services to produce our third campaign of IMP shortly after this date, but the factory had to close in March due to issues with their production unit.
    16 Apr 2018

    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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