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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Subjects with Pain Associated with Fibromyalgia

    Summary
    EudraCT number
    2013-005163-10
    Trial protocol
    GB   SK   EE   LT   HU   LV   BG  
    Global end of trial date
    07 Jul 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    04 Nov 2017
    First version publication date
    25 Aug 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    The actual end of trial date was 07-July-2016, so the record is updated accordingly.

    Trial information

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    Trial identification
    Sponsor protocol code
    DS5565-A-E311
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02187159
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc.
    Sponsor organisation address
    211 Mt. Airy Road, Basking Ridge, United States, 07920
    Public contact
    Clinical Trial Application, Daiichi Sankyo Development Ltd, +44 1753482800, euregaffairs@dsd-eu.com
    Scientific contact
    Clinical Trial Application, Daiichi Sankyo Development Ltd, +44 1753482800, euregaffairs@dsd-eu.com
    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
    02 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.
    Protection of trial subjects
    This trial was conducted under ICH E6 Good Clinical Practices, which has it's foundation in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Nov 2014
    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
    Slovakia: 41
    Country: Number of subjects enrolled
    United Kingdom: 153
    Country: Number of subjects enrolled
    United States: 752
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Bulgaria: 74
    Country: Number of subjects enrolled
    Estonia: 21
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    India: 44
    Country: Number of subjects enrolled
    Latvia: 32
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    New Zealand: 33
    Country: Number of subjects enrolled
    Romania: 31
    Country: Number of subjects enrolled
    Russian Federation: 39
    Worldwide total number of subjects
    1270
    EEA total number of subjects
    382
    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)
    1146
    From 65 to 84 years
    124
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of 2280 patients screened, 1270 from 13 countries were randomized into study groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Patients take one each of placebo tablet and capsule, twice daily (BID)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo tablet and/or capsule
    Investigational medicinal product code
    Other name
    Matching Placebo
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for oral administration matching tablet for DS-5565 and matching capsule for pregabalin

    Arm title
    Pregabalin
    Arm description
    Patients take one pregabalin capsule and one placebo tablet BID
    Arm type
    Active comparator

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin 150 mg capsule for oral administration

    Investigational medicinal product name
    Placebo tablet and/or capsule
    Investigational medicinal product code
    Other name
    Matching Placebo
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for oral administration matching tablet for DS-5565 and matching capsule for pregabalin

    Arm title
    DS-5565 QD
    Arm description
    Patients take one each of placebo tablet and capsule in the morning and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening
    Arm type
    Active comparator

    Investigational medicinal product name
    DS-5565
    Investigational medicinal product code
    Other name
    mirogabalin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DS-5565 15 mg tablet for oral administration

    Investigational medicinal product name
    Placebo tablet and/or capsule
    Investigational medicinal product code
    Other name
    Matching Placebo
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for oral administration matching tablet for DS-5565 and matching capsule for pregabalin

    Arm title
    DS-5565 BID
    Arm description
    Patients take one DS-5565 tablet and one placebo capsule BID
    Arm type
    Experimental

    Investigational medicinal product name
    DS-5565
    Investigational medicinal product code
    Other name
    mirogabalin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DS-5565 15 mg tablet for oral administration

    Investigational medicinal product name
    Placebo tablet and/or capsule
    Investigational medicinal product code
    Other name
    Matching Placebo
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for oral administration matching tablet for DS-5565 and matching capsule for pregabalin

    Number of subjects in period 1
    Placebo Pregabalin DS-5565 QD DS-5565 BID
    Started
    318
    317
    318
    317
    Safety analysis set
    315
    312
    315
    313
    Modified intent to treat set (mITT)
    315
    312
    315
    313
    Completed double-blind treatment
    249
    238
    241
    221
    Completed
    249
    238
    241
    221
    Not completed
    69
    79
    77
    96
         Protocol deviation
    4
    6
    3
    4
         Lack of efficacy
    10
    5
    4
    7
         Adverse event, non-fatal
    28
    33
    42
    50
         Reason missing or not reported
    3
    7
    3
    9
         Consent withdrawn by subject
    24
    28
    25
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients take one each of placebo tablet and capsule, twice daily (BID)

    Reporting group title
    Pregabalin
    Reporting group description
    Patients take one pregabalin capsule and one placebo tablet BID

    Reporting group title
    DS-5565 QD
    Reporting group description
    Patients take one each of placebo tablet and capsule in the morning and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening

    Reporting group title
    DS-5565 BID
    Reporting group description
    Patients take one DS-5565 tablet and one placebo capsule BID

    Reporting group values
    Placebo Pregabalin DS-5565 QD DS-5565 BID Total
    Number of subjects
    318 317 318 317 1270
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    289 287 286 284 1146
        From 65-84 years
    29 30 32 33 124
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.2 ± 11.43 50.9 ± 11.58 50.2 ± 11.85 50.6 ± 11.46 -
    Gender categorical
    Units: Subjects
        Female
    290 288 295 287 1160
        Male
    28 29 23 30 110

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients take one each of placebo tablet and capsule, twice daily (BID)

    Reporting group title
    Pregabalin
    Reporting group description
    Patients take one pregabalin capsule and one placebo tablet BID

    Reporting group title
    DS-5565 QD
    Reporting group description
    Patients take one each of placebo tablet and capsule in the morning and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening

    Reporting group title
    DS-5565 BID
    Reporting group description
    Patients take one DS-5565 tablet and one placebo capsule BID

    Primary: Average daily pain score (ADPS) for either dose of DS-5565 versus placebo

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    End point title
    Average daily pain score (ADPS) for either dose of DS-5565 versus placebo [1] [2]
    End point description
    Average daily pain scores reported by the patient that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.
    End point type
    Primary
    End point timeframe
    Baseline, Week 13
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were performed to arrive at this aggregate summary data.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pregabalin was not included in this outcome measure
    End point values
    Placebo DS-5565 QD DS-5565 BID
    Number of subjects analysed
    315
    315
    313
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.04 ± 1.282
    7.08 ± 1.209
    7.13 ± 1.301
        Week 13 (MI)
    5.21 ± 0.13
    4.83 ± 0.133
    4.98 ± 0.134
    No statistical analyses for this end point

    Secondary: Number of patients who answered "much improved or better" in PGIC at Week 13 receiving either dose of DS-5565 versus placebo

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    End point title
    Number of patients who answered "much improved or better" in PGIC at Week 13 receiving either dose of DS-5565 versus placebo [3]
    End point description
    Patients rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse
    End point type
    Secondary
    End point timeframe
    Baseline, Week 13
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pregabalin was not included in this outcome measure.
    End point values
    Placebo DS-5565 QD DS-5565 BID
    Number of subjects analysed
    315
    315
    313
    Units: Patients
    84
    106
    104
    No statistical analyses for this end point

    Secondary: Average score on the fibromyalgia index questionnaire (FIQ) in patients receiving either dose of DS-5565 or placebo

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    End point title
    Average score on the fibromyalgia index questionnaire (FIQ) in patients receiving either dose of DS-5565 or placebo [4]
    End point description
    The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4-point Likert-type scale. Items 2 and 3 ask the patient to mark the number of days that they feel well and the number of days they were unable to work (including housework) because of fibromyalgia (FM) symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. A higher score indicates a greater impact of the syndrome on the patient. Scores were collected from patients who completed the assessment at the given time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 13
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pregabalin was not included in this outcome measure
    End point values
    Placebo DS-5565 QD DS-5565 BID
    Number of subjects analysed
    315
    315
    313
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=313,312,312)
    62.87 ± 13.399
    63.96 ± 12.953
    63.28 ± 13.304
        Week 13 (MI; n=246,238,220)
    48.78 ± 20.171
    46.59 ± 21.065
    45.17 ± 19.378
    No statistical analyses for this end point

    Secondary: Number of patients receiving either dose of DS-5565 or placebo classified as responders at Week 13

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    End point title
    Number of patients receiving either dose of DS-5565 or placebo classified as responders at Week 13 [5]
    End point description
    Patients classified as responders are those with a substantial reduction in ADPS in Week 13 compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 13
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pregabalin was not included in this outcome measure
    End point values
    Placebo DS-5565 QD DS-5565 BID
    Number of subjects analysed
    315
    315
    313
    Units: Patients
        30% Responders
    113
    123
    118
        50% Responders
    61
    79
    68
    No statistical analyses for this end point

    Secondary: Average daily pain score (ADPS) for pregabalin

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    End point title
    Average daily pain score (ADPS) for pregabalin [6]
    End point description
    Average daily pain scores reported by the patient that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 13
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pregabalin was reported separately
    End point values
    Pregabalin
    Number of subjects analysed
    312
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=311)
    7.03 ± 1.392
        Week 13 (MI; n=312)
    4.6 ± 0.133
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Events that emerge or get worse on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication
    Adverse event reporting additional description
    Total number of treatment-emergent adverse events (TEAEs) counts all occurrences in all subjects. In the system organ class and preferred term summarization, a patient was counted only once when one or more events were reported, so the occurrences mirror the number of patients.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients take one each of placebo tablet and capsule, twice daily (BID)

    Reporting group title
    Pregabalin
    Reporting group description
    Patients take one pregabalin capsule and one placebo tablet BID

    Reporting group title
    DS-5565 QD
    Reporting group description
    Patients take one each of placebo tablet and capsule in the morning and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening

    Reporting group title
    DS-5565 BID
    Reporting group description
    Patients take one DS-5565 tablet and one placebo capsule BID

    Serious adverse events
    Placebo Pregabalin DS-5565 QD DS-5565 BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 315 (1.90%)
    5 / 312 (1.60%)
    7 / 315 (2.22%)
    11 / 313 (3.51%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lip squamous cell carcinoma
         subjects affected / exposed
    1 / 315 (0.32%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    2 / 313 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 315 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 315 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiomegaly
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 315 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alveolitis allergic
         subjects affected / exposed
    1 / 315 (0.32%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 315 (0.32%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    0 / 315 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 315 (0.32%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 315 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 315 (0.32%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 315 (0.32%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 315 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 315 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Pregabalin DS-5565 QD DS-5565 BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    212 / 315 (67.30%)
    221 / 312 (70.83%)
    233 / 315 (73.97%)
    238 / 313 (76.04%)
    Investigations
    Weight increased
         subjects affected / exposed
    9 / 315 (2.86%)
    39 / 312 (12.50%)
    17 / 315 (5.40%)
    33 / 313 (10.54%)
         occurrences all number
    9
    39
    17
    33
    Nervous system disorders
    Headache
         subjects affected / exposed
    39 / 315 (12.38%)
    37 / 312 (11.86%)
    44 / 315 (13.97%)
    45 / 313 (14.38%)
         occurrences all number
    39
    37
    44
    45
    Dizziness
         subjects affected / exposed
    23 / 315 (7.30%)
    47 / 312 (15.06%)
    44 / 315 (13.97%)
    41 / 313 (13.10%)
         occurrences all number
    23
    47
    44
    41
    Somnolence
         subjects affected / exposed
    10 / 315 (3.17%)
    29 / 312 (9.29%)
    23 / 315 (7.30%)
    29 / 313 (9.27%)
         occurrences all number
    10
    29
    23
    29
    Eye disorders
    Vision blurred
         subjects affected / exposed
    5 / 315 (1.59%)
    14 / 312 (4.49%)
    16 / 315 (5.08%)
    13 / 313 (4.15%)
         occurrences all number
    5
    14
    16
    13
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    20 / 315 (6.35%)
    32 / 312 (10.26%)
    32 / 315 (10.16%)
    28 / 313 (8.95%)
         occurrences all number
    20
    32
    32
    28
    Fatigue
         subjects affected / exposed
    9 / 315 (2.86%)
    11 / 312 (3.53%)
    17 / 315 (5.40%)
    11 / 313 (3.51%)
         occurrences all number
    9
    11
    17
    11
    Oedema peripheral
         subjects affected / exposed
    4 / 315 (1.27%)
    10 / 312 (3.21%)
    9 / 315 (2.86%)
    16 / 313 (5.11%)
         occurrences all number
    4
    10
    9
    16
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    14 / 315 (4.44%)
    10 / 312 (3.21%)
    18 / 315 (5.71%)
    28 / 313 (8.95%)
         occurrences all number
    14
    10
    18
    28
    Diarrhoea
         subjects affected / exposed
    15 / 315 (4.76%)
    15 / 312 (4.81%)
    20 / 315 (6.35%)
    14 / 313 (4.47%)
         occurrences all number
    15
    15
    20
    14
    Musculoskeletal and connective tissue disorders
    Fibromyalgia
         subjects affected / exposed
    16 / 315 (5.08%)
    15 / 312 (4.81%)
    10 / 315 (3.17%)
    16 / 313 (5.11%)
         occurrences all number
    16
    15
    10
    16
    Back pain
         subjects affected / exposed
    17 / 315 (5.40%)
    8 / 312 (2.56%)
    12 / 315 (3.81%)
    11 / 313 (3.51%)
         occurrences all number
    17
    8
    12
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 315 (5.40%)
    19 / 312 (6.09%)
    17 / 315 (5.40%)
    20 / 313 (6.39%)
         occurrences all number
    17
    19
    17
    20
    Urinary tract infection
         subjects affected / exposed
    6 / 315 (1.90%)
    13 / 312 (4.17%)
    11 / 315 (3.49%)
    17 / 313 (5.43%)
         occurrences all number
    6
    13
    11
    17

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2015
    Update and clarify screening procedures and duration. Update and provide further direction on how to deal with borderline pregnancy results.
    29 Jul 2015
    Clarify study objectives, endpoints, pain assessment and study procedures
    06 Apr 2016
    Modify and clarify discontinuation criteria.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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