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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
    2013-005162-20
    Trial protocol
    AT   BE   ES   PT   SI   PL  
    Global end of trial date
    12 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Dec 2017
    First version publication date
    08 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DS5565-A-E310
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02187471
    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 Information Contact, Daiichi Sankyo, Inc., +1 7325905000, eu_cta@dsi.com
    Scientific contact
    Clinical Trial Information Contact, Daiichi Sankyo, Inc., +1 7325905000, eu_cta@dsi.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
    09 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2017
    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 Practice, which has its foundation in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 11
    Country: Number of subjects enrolled
    Spain: 101
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Ukraine: 74
    Country: Number of subjects enrolled
    United States: 760
    Country: Number of subjects enrolled
    Argentina: 88
    Country: Number of subjects enrolled
    Austria: 29
    Country: Number of subjects enrolled
    Belarus: 12
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Chile: 45
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    Mexico: 29
    Country: Number of subjects enrolled
    Poland: 86
    Country: Number of subjects enrolled
    Portugal: 22
    Country: Number of subjects enrolled
    Russian Federation: 27
    Worldwide total number of subjects
    1301
    EEA total number of subjects
    264
    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)
    1174
    From 65 to 84 years
    127
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of 2526 patients screened, 1301 from 15 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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet matching DS-5565 tablet

    Investigational medicinal product name
    Placebo capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule matching pregabalin capsule

    Arm title
    Pregabalin
    Arm description
    Patients take one pregabalin capsule and one placebo tablet BID
    Arm type
    Other product - not comparator

    Investigational medicinal product name
    Pregabalin capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg capsule for one week, then 150 mg capsule

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet matching DS-5565 tablet

    Arm title
    DS5565 15 mg QD
    Arm description
    Patients take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet, once daily (QD)
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet matching DS-5565 tablet

    Investigational medicinal product name
    Placebo capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule matching pregabalin capsule

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

    Arm title
    DS5565 15 mg BID
    Arm description
    Patients take one DS-5565 tablet and one placebo capsule BID
    Arm type
    Experimental

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

    Investigational medicinal product name
    Placebo capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule matching pregabalin capsule

    Number of subjects in period 1
    Placebo Pregabalin DS5565 15 mg QD DS5565 15 mg BID
    Started
    325
    324
    326
    326
    Completed Double-Blind Treatment Period
    249
    242
    240
    246
    Completed Tapering Period
    278
    269
    263
    273
    Completed Follow-up
    194 [1]
    193 [2]
    199 [3]
    194 [4]
    Entered Open-label Extension Study
    99 [5]
    88 [6]
    84 [7]
    100 [8]
    Safety Analysis Set
    324
    319
    324
    323
    mITT Analysis Set
    324
    319
    324
    323
    Completed
    249
    242
    240
    246
    Not completed
    76
    82
    86
    80
         Protocol deviation
    4
    5
    4
    4
         Missing
    -
    -
    -
    1
         Lack of efficacy
    18
    9
    13
    11
         Adverse event, non-fatal
    24
    34
    44
    36
         Consent withdrawn by subject
    23
    29
    22
    24
         No reason provided
    7
    5
    3
    4
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of patients who completed the treatment period are considered as having completed the trial.

    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
    DS5565 15 mg QD
    Reporting group description
    Patients take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet, once daily (QD)

    Reporting group title
    DS5565 15 mg BID
    Reporting group description
    Patients take one DS-5565 tablet and one placebo capsule BID

    Reporting group values
    Placebo Pregabalin DS5565 15 mg QD DS5565 15 mg BID Total
    Number of subjects
    325 324 326 326 1301
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    296 294 294 290 1174
        From 65-84 years
    29 30 32 36 127
    Gender categorical
    Units: Subjects
        Female
    303 302 302 296 1203
        Male
    22 22 24 30 98

    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
    DS5565 15 mg QD
    Reporting group description
    Patients take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet, once daily (QD)

    Reporting group title
    DS5565 15 mg 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. For patients with no Week 13 data, the baseline observation was carried forward (BOCF).
    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 further statistical analysis was performed to arrive at this summary aggregate 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: Only pregabalin was included in this endpoint.
    End point values
    Placebo DS5565 15 mg QD DS5565 15 mg BID
    Number of subjects analysed
    323
    324
    323
    Units: scores on a scale
    arithmetic mean (standard deviation)
        at Baseline
    7.20 ± 1.393
    7.23 ± 1.357
    7.24 ± 1.436
        at Week 13
    5.53 ± 2.462
    5.51 ± 1.486
    5.30 ± 2.724
    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 endpoint.
    End point values
    Placebo DS5565 15 mg QD DS5565 15 mg BID
    Number of subjects analysed
    324
    324
    323
    Units: Patients
    85
    120
    129
    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 endpoint.
    End point values
    Placebo DS5565 15 mg QD DS5565 15 mg BID
    Number of subjects analysed
    324
    324
    323
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        at Baseline (n=322,323,320)
    66.02 ± 14.071
    63.26 ± 13.822
    64.48 ± 13.615
        at Week 13 (n=249,240,246)
    47.80 ± 20.248
    43.86 ± 20.714
    41.04 ± 22.115
    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 (BOCF) 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 endpoint.
    End point values
    Placebo DS5565 15 mg QD DS5565 15 mg BID
    Number of subjects analysed
    324
    324
    323
    Units: Patients
        30% Responders
    122
    121
    125
        50% Responders
    68
    77
    89
    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. For patients with no Week 13 data, the baseline observation was carried forward (BOCF).
    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 not included in this endpoint.
    End point values
    Pregabalin
    Number of subjects analysed
    319
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        at Baseline
    7.22 ± 1.326
        at Week 13
    5.12 ± 2.510
    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 pregabalin capsule and one placebo tablet BID

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

    Reporting group title
    DS5565 15 mg QD
    Reporting group description
    Patients take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet, once daily (QD)

    Reporting group title
    DS5565 15 mg BID
    Reporting group description
    Patients take one DS-5565 tablet and one placebo capsule BID

    Serious adverse events
    Placebo Pregabalin DS5565 15 mg QD DS5565 15 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 324 (2.78%)
    2 / 319 (0.63%)
    5 / 324 (1.54%)
    5 / 323 (1.55%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    1 / 323 (0.31%)
         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
    Nervous system disorders
    Uraemic encephalopathy
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    1 / 323 (0.31%)
         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
    Convulsion
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Seizure like phenomena
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 319 (0.31%)
    0 / 324 (0.00%)
    0 / 323 (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
    Transient ischaemic attack
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 319 (0.31%)
    0 / 324 (0.00%)
    0 / 323 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    1 / 324 (0.31%)
    0 / 323 (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
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    1 / 324 (0.31%)
    0 / 323 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    1 / 324 (0.31%)
    0 / 323 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    1 / 323 (0.31%)
         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
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    1 / 323 (0.31%)
         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
    Nephrolithiasis
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    1 / 324 (0.31%)
    0 / 323 (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
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Infections and infestations
    Pyelonephritis acute
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    1 / 323 (0.31%)
         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
    Urinary tract infection
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    1 / 323 (0.31%)
         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
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 324 (0.00%)
    0 / 319 (0.00%)
    1 / 324 (0.31%)
    0 / 323 (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
    Abdominal wall abscess
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Pneumonia
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 319 (0.00%)
    0 / 324 (0.00%)
    0 / 323 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Pregabalin DS5565 15 mg QD DS5565 15 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    214 / 324 (66.05%)
    243 / 319 (76.18%)
    247 / 324 (76.23%)
    247 / 323 (76.47%)
    Investigations
    Weight increased
         subjects affected / exposed
    22 / 324 (6.79%)
    49 / 319 (15.36%)
    26 / 324 (8.02%)
    34 / 323 (10.53%)
         occurrences all number
    22
    49
    26
    34
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    17 / 324 (5.25%)
    56 / 319 (17.55%)
    47 / 324 (14.51%)
    36 / 323 (11.15%)
         occurrences all number
    17
    56
    47
    36
    Headache
         subjects affected / exposed
    50 / 324 (15.43%)
    41 / 319 (12.85%)
    39 / 324 (12.04%)
    31 / 323 (9.60%)
         occurrences all number
    50
    41
    39
    31
    Somnolence
         subjects affected / exposed
    9 / 324 (2.78%)
    40 / 319 (12.54%)
    29 / 324 (8.95%)
    39 / 323 (12.07%)
         occurrences all number
    9
    40
    29
    39
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    10 / 324 (3.09%)
    12 / 319 (3.76%)
    15 / 324 (4.63%)
    21 / 323 (6.50%)
         occurrences all number
    10
    12
    15
    21
    Oedema peripheral
         subjects affected / exposed
    4 / 324 (1.23%)
    18 / 319 (5.64%)
    11 / 324 (3.40%)
    15 / 323 (4.64%)
         occurrences all number
    4
    18
    11
    15
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    11 / 324 (3.40%)
    18 / 319 (5.64%)
    25 / 324 (7.72%)
    20 / 323 (6.19%)
         occurrences all number
    11
    18
    25
    20
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 324 (3.40%)
    11 / 319 (3.45%)
    18 / 324 (5.56%)
    7 / 323 (2.17%)
         occurrences all number
    11
    11
    18
    7
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    14 / 324 (4.32%)
    10 / 319 (3.13%)
    20 / 324 (6.17%)
    16 / 323 (4.95%)
         occurrences all number
    14
    10
    20
    16
    Nasopharyngitis
         subjects affected / exposed
    13 / 324 (4.01%)
    19 / 319 (5.96%)
    13 / 324 (4.01%)
    14 / 323 (4.33%)
         occurrences all number
    13
    19
    13
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2014
    Made multiple changes based on sponsor decision and FDA feedback. Amendment occurred before first subject first visit, so all changes were incorporated into the initial informed consent.
    29 Jan 2015
    Clarified and added eligibility criteria and screening methods. and increased screening window.
    07 Apr 2016
    Modified inclusion exclusion criteria to reflect DSMB's recommendation to screen for suicidality.
    15 Dec 2016
    Changed order of objectives and statistical analysis plan.

    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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