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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
    		 2013-005161-40
    Trial protocol
    		 SE   DE   DK   CZ   FI   NL  
    Global end of trial date
    19 Aug 2016

    Results information
    Results version number
    		 v1
    This version publication date
    25 Aug 2017
    First version publication date
    25 Aug 2017
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    DS5565-A-E309
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02146430
    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
    19 Aug 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 its foundation in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 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
    Netherlands: 12
    Country: Number of subjects enrolled
    Norway: 69
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    Czech Republic: 77
    Country: Number of subjects enrolled
    Denmark: 26
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Germany: 168
    Country: Number of subjects enrolled
    Canada: 120
    Country: Number of subjects enrolled
    Serbia: 62
    Country: Number of subjects enrolled
    United States: 711
    Worldwide total number of subjects
    1293
    EEA total number of subjects
    400
    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)
    1183
    From 65 to 84 years
    109
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of 2318 patients, 1293 from 11 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
    		 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

    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 Tablet
    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
    323
    323
    324
    323
    Safety Analysis Set
    318
    318
    320
    320
    Modified intent to treat set (mITT)
    318
    317
    319
    319
    Completed double-blind treatment period
    256
    236
    242
    224
    Completed
    256
    236
    242
    224
    Not completed
    67
    87
    82
    99
         Consent withdrawn by subject
    27
    29
    30
    34
         Adverse event, non-fatal
    20
    40
    32
    49
         Reason missing or not reported
    2
    3
    4
    5
         Lack of efficacy
    13
    11
    8
    5
         Protocol deviation
    5
    4
    8
    6

    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
    		 323 323 324 323 1293
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 298 298 300 287 1183
        From 65-84 years
    		 25 24 24 36 109
        85 years and over
    		 0 1 0 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.6 ( 11.76 ) 49.5 ( 11.53 ) 50.3 ( 10.88 ) 49.5 ( 11.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 299 292 286 291 1168
        Male
    		 24 31 38 32 125

    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 of 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 the 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 reported separately
    End point values
    		 Placebo DS-5565 QD DS-5565 BID
    Number of subjects analysed
    317
    318
    318
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=317,318,318)
    7.19 ( 1.3 )
    7.13 ( 1.358 )
    7.19 ( 1.295 )
        Week 13 (MI, n=317,319,318)
    5.47 ( 0.132 )
    5.16 ( 0.134 )
    5.19 ( 0.136 )
    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
    318
    319
    319
    Units: Patients
    78
    94
    71
    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
    318
    319
    319
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=316,316,318)
    65.2 ( 13.629 )
    64.51 ( 13.92 )
    64.21 ( 13.175 )
        Week 13 (n=255,240,224)
    49.81 ( 20.149 )
    47.65 ( 19.4 )
    48.87 ( 18.928 )
    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
    318
    319
    319
    Units: Patients
        30% responders
    101
    106
    100
        50% responders
    57
    71
    57
    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 of 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
    317
    Units: Scores on a scale
    least squares mean (standard error)
        Baseline
    7 ( 1.323 )
        Week 13
    5.22 ( 0.134 )
    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
    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 DS-5565 tablet once daily (QD) with a placebo capsule, and a placebo capsule and tablet at the other dosing session

    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
    11 / 318 (3.46%)
    2 / 318 (0.63%)
    5 / 320 (1.56%)
    8 / 320 (2.50%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 318 (0.31%)
    0 / 320 (0.00%)
    0 / 320 (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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    2 / 320 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    1 / 320 (0.31%)
    0 / 320 (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
    Pyrexia
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    1 / 320 (0.31%)
    0 / 320 (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
    Salivary gland calculus
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Reproductive system and breast disorders
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 318 (0.31%)
    0 / 320 (0.00%)
    0 / 320 (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
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    1 / 320 (0.31%)
    0 / 320 (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
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    1 / 320 (0.31%)
    0 / 320 (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
    Bronchospasm
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    1 / 320 (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
    Withdrawal syndrome
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 318 (0.31%)
    0 / 320 (0.00%)
    1 / 320 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Musculoskeletal and connective tissue disorders
    Back disorder
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    1 / 320 (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
    Back pain
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    1 / 320 (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
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Appendicitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    1 / 320 (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
    Bronchitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    1 / 320 (0.31%)
    0 / 320 (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
    Infectious colitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    1 / 320 (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
    Staphylococcal infection
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 318 (0.00%)
    1 / 320 (0.31%)
    0 / 320 (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
    Cellulitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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
    Sepsis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 318 (0.00%)
    0 / 320 (0.00%)
    0 / 320 (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 DS-5565 QD DS-5565 BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    207 / 318 (65.09%)
    247 / 318 (77.67%)
    227 / 320 (70.94%)
    249 / 320 (77.81%)
    Investigations
    Weight increased
         subjects affected / exposed
    16 / 318 (5.03%)
    36 / 318 (11.32%)
    21 / 320 (6.56%)
    26 / 320 (8.13%)
         occurrences all number
    16
    26
    31
    36
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    20 / 318 (6.29%)
    65 / 318 (20.44%)
    53 / 320 (16.56%)
    71 / 320 (22.19%)
         occurrences all number
    20
    65
    53
    71
    Headache
         subjects affected / exposed
    36 / 318 (11.32%)
    48 / 318 (15.09%)
    45 / 320 (14.06%)
    55 / 320 (17.19%)
         occurrences all number
    36
    48
    45
    55
    Somnolence
         subjects affected / exposed
    7 / 318 (2.20%)
    37 / 318 (11.64%)
    25 / 320 (7.81%)
    39 / 320 (12.19%)
         occurrences all number
    7
    37
    25
    39
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 318 (3.14%)
    23 / 318 (7.23%)
    23 / 320 (7.19%)
    36 / 320 (11.25%)
         occurrences all number
    10
    23
    23
    36
    Oedema peripheral
         subjects affected / exposed
    11 / 318 (3.46%)
    19 / 318 (5.97%)
    14 / 320 (4.38%)
    11 / 320 (3.44%)
         occurrences all number
    11
    19
    14
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    19 / 318 (5.97%)
    27 / 318 (8.49%)
    27 / 320 (8.44%)
    36 / 320 (11.25%)
         occurrences all number
    19
    27
    27
    36
    Dry mouth
         subjects affected / exposed
    5 / 318 (1.57%)
    21 / 318 (6.60%)
    15 / 320 (4.69%)
    18 / 320 (5.63%)
         occurrences all number
    5
    21
    15
    18
    Diarrhoea
         subjects affected / exposed
    14 / 318 (4.40%)
    10 / 318 (3.14%)
    10 / 320 (3.13%)
    16 / 320 (5.00%)
         occurrences all number
    14
    10
    10
    16
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 318 (2.20%)
    13 / 318 (4.09%)
    16 / 320 (5.00%)
    22 / 320 (6.88%)
         occurrences all number
    7
    13
    16
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2014
    Clarify study objectives, endpoints, pain assessment and study procedures
    29 Jan 2015
    Update and clarify screening procedures and duration. Update and provide further direction on how to deal with borderline pregnancy results.
    07 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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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