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Treatment of Pain Associated With Fibromyalgia

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02187159
Collaborator
Syneos Health (Other)
1,270
Enrollment
176
Locations
4
Arms
20.2
Actual Duration (Months)
7.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Jul 7, 2016
Actual Study Completion Date :
Jul 7, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: DS-5565 QD

Participants 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

Drug: DS-5565
DS-5565 15 mg tablet for oral administration
Other Names:
  • mirogabalin

    • Drug: Placebo tablet
    Placebo tablet (matching DS5565) for oral administration
    Other Names:
  • Placebo matching DS-5565

    • Drug: Placebo capsule
    Placebo capsule (matching pregabalin) for oral administration
    Other Names:
  • Placebo matching pregabalin

    		•
    Experimental: DS-5565 BID

    Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)

    Drug: DS-5565
    DS-5565 15 mg tablet for oral administration
    Other Names:
  • mirogabalin

    • Drug: Placebo capsule
    Placebo capsule (matching pregabalin) for oral administration
    Other Names:
  • Placebo matching pregabalin

    		•
    Active Comparator: Pregabalin

    Participants take one pregabalin capsule and one placebo tablet BID

    Drug: Pregabalin
    Pregabalin 150 mg capsule for oral administration
    Other Names:
  • Lyrica

    • Drug: Placebo tablet
    Placebo tablet (matching DS5565) for oral administration
    Other Names:
  • Placebo matching DS-5565

    		•
    Placebo Comparator: Placebo

    Participants take one each of placebo tablet and capsule BID

    Drug: Placebo tablet
    Placebo tablet (matching DS5565) for oral administration
    Other Names:
  • Placebo matching DS-5565

    • Drug: Placebo capsule
    Placebo capsule (matching pregabalin) for oral administration
    Other Names:
  • Placebo matching pregabalin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.

    Secondary Outcome Measures

    1. Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo [Week 13 postdose]

      Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" (≤2 scores) are reported.

    2. Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome. For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.

    3. Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo [Week 13 postdose]

      The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.

    4. Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue). For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.

    5. Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).

    6. Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 scale ranges from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) scores are reported.

    7. Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome. For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.

    8. Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week.

    9. The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo [Week 13 postdose]

      The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).

    10. Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo [Baseline up to Week 13 postdose]

      The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.

    11. Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo [Week 1 to Week 13 postdose]

      Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 18 years

    • Able to give written informed consent

    • Able to complete subject-reported questionnaires per the investigator's judgment

    • At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:

    • Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9

    • Symptoms have been present at a similar level for at least 3 months

    • The subject does not have a disorder that would otherwise explain the pain

    • ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)

    • Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening.

    • Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion.

    Exclusion Criteria:

    • Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months prior to screening that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability

    • Anticipation of initiation or significant change to normal daily exercise routines or need for ongoing use of concomitant medications or non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety

    • Unable to undergo pre-study washout of prohibited concomitant medications

    • Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Patients answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such patients should be referred immediately to a mental health professional for appropriate evaluation.

    • Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study.

    • Any diagnosis of lifetime bipolar disorder or psychotic disorder

    • Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM.

    • Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.

    • Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year

    • Any history of a malignancy other than basal cell carcinoma within the past 5 years

    • A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months

    • Pregnancy or breast-feeding, or intent to become pregnant during the study period

    • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.

    • Known hypersensitivity to alpha2-delta (α2δ) ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.

    • Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study.

    • Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values judged by the investigator to be clinically significant at screening, with particular focus on: a. Abnormal renal function defined as calculated creatinine clearance (CrCl) < 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen> 1.5 × upper limit of normal (ULN); creatine kinase > 3.0 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 μmol/L); b. Abnormal liver function defined as aspartate aminotransferase (AST) > 2.0 × ULN, alanine aminotransferase (ALT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mobile Alabama United States 36608
    2 Phoenix Arizona United States 85027
    3 Scottsdale Arizona United States
    4 Little Rock Arkansas United States 72205
    5 Fresno California United States 93710
    6 Glendale California United States 91204
    7 Orange California United States 92868
    8 Oxnard California United States
    9 Richmond California United States 94806
    10 Sacramento California United States
    11 San Diego California United States 92103
    12 Santa Ana California United States 92705
    13 Santa Barbara California United States 93108
    14 Simi Valley California United States 93065
    15 New London Connecticut United States
    16 Bradenton Florida United States 34208
    17 Brandon Florida United States 33511
    18 DeBary Florida United States 32713
    19 Fort Myers Florida United States 33916
    20 Hialeah Florida United States 33013
    21 Homestead Florida United States 33030
    22 Lake Mary Florida United States
    23 Miami Florida United States 33126
    24 North Miami Florida United States 33161
    25 Ocala Florida United States 34471
    26 Plant City Florida United States 33563
    27 Tampa Florida United States 33614
    28 Alpharetta Georgia United States 30005
    29 Atlanta Georgia United States 30328
    30 Atlanta Georgia United States 30342
    31 Columbus Georgia United States 31904
    32 Savannah Georgia United States 31405
    33 Boise Idaho United States 83713
    34 Meridian Idaho United States 83642
    35 Chicago Illinois United States 60611
    36 Gurnee Illinois United States 60031
    37 Naperville Illinois United States 60563
    38 Evansville Indiana United States 47714
    39 West Des Moines Iowa United States 50266
    40 Shawnee Mission Kansas United States 66218
    41 Wichita Kansas United States 67205
    42 Lexington Kentucky United States 40509
    43 Monroe Louisiana United States 71201
    44 Traverse City Michigan United States 49684
    45 Jackson Mississippi United States 39202
    46 Omaha Nebraska United States 68134
    47 Las Vegas Nevada United States 89123
    48 Brooklyn New York United States 11229
    49 Manhasset New York United States
    50 New York New York United States 10128
    51 Staten Island New York United States 10312
    52 Benson North Carolina United States
    53 Greensboro North Carolina United States 27408
    54 Raleigh North Carolina United States 27609
    55 Salisbury North Carolina United States
    56 Fargo North Dakota United States 58103
    57 Cleveland Ohio United States 44122
    58 Columbus Ohio United States
    59 Dayton Ohio United States 45424
    60 Garfield Heights Ohio United States 44125
    61 Middleburg Heights Ohio United States
    62 Tiffin Ohio United States 44883
    63 Oklahoma City Oklahoma United States 73103
    64 Tulsa Oklahoma United States 74104
    65 Salem Oregon United States 97301
    66 Duncansville Pennsylvania United States 16635
    67 Warwick Rhode Island United States
    68 Anderson South Carolina United States 29621
    69 Charleston South Carolina United States 29406
    70 Greer South Carolina United States 29650
    71 Rock Hill South Carolina United States 28209
    72 Bristol Tennessee United States 37620
    73 Knoxville Tennessee United States 37919
    74 New Tazewell Tennessee United States 37825
    75 Austin Texas United States 78705
    76 Dallas Texas United States 75231
    77 Houston Texas United States 77070
    78 Houston Texas United States 77089
    79 San Antonio Texas United States 78229
    80 Sealy Texas United States 77474
    81 Sugar Land Texas United States 77479
    82 Salt Lake City Utah United States 84102
    83 Norfolk Virginia United States 23507
    84 Richmond Virginia United States 23294
    85 Kirkland Washington United States 98033
    86 Charleston West Virginia United States 25304
    87 Camperdown New South Wales Australia
    88 Campsie New South Wales Australia 2194
    89 Coffs Harbour New South Wales Australia 2450
    90 St. Leonards New South Wales Australia
    91 Maroochydore Queensland Australia 4558
    92 Sherwood Queensland Australia
    93 Southport Queensland Australia 4215
    94 Woodsville South Australia Australia
    95 Hobart Tasmania Australia 7000
    96 Clayton Victoria Australia
    97 Malvern East Victoria Australia 3145
    98 Burgas Bulgaria
    99 Pleven Bulgaria
    100 Plovdiv Bulgaria
    101 Ruse Bulgaria
    102 Sevlievo Bulgaria
    103 Sofia Bulgaria
    104 Targovishte Bulgaria
    105 Varna Bulgaria
    106 Tallin Estonia
    107 Tartu Estonia 51013
    108 Balassagyarmat Hungary
    109 Budapest Hungary
    110 Debrecen Hungary
    111 Esztergom Hungary
    112 Kistarcsa Hungary
    113 Nyiregyhaza Hungary
    114 Szeged Hungary
    115 Veszprem Hungary
    116 Ahmedabad Gujarat India
    117 Surat Gujarat India
    118 Bangalore Karnataka India
    119 Hubli Karnataka India
    120 Pune Maharashtra India
    121 Jaipur Rajasthan India
    122 Lucknow VP India
    123 Baldone Latvia LV-2155
    124 Balvi Latvia
    125 Jekabpils Latvia LV-5201
    126 Liepaja Latvia LV-3401
    127 Ogre Latvia LV-5001
    128 Riga Latvia
    129 Ventspils Latvia
    130 Auckland New Zealand 2025
    131 Hamilton New Zealand 3204
    132 Nelson New Zealand 7010
    133 Tauranga New Zealand 3110
    134 Wellington New Zealand 6242
    135 Bacau Romania
    136 Bucharest Romania
    137 Cluj Napoca Romania
    138 Oradea Romania
    139 Targu Mures Romania
    140 Ivanovo Russian Federation
    141 Krasnoyarsk Russian Federation
    142 Moscow Russian Federation
    143 Nizhniy Novgorod Russian Federation
    144 Orenburgsky Russian Federation
    145 Pyatigorski Russian Federation
    146 St. Petersburg Russian Federation
    147 Stavropol Russian Federation
    148 Vladikavkaz Russian Federation
    149 Yaroslav Russian Federation
    150 Banska Bystrica Slovakia 974 04
    151 Bratislava Slovakia 821 08
    152 Dubnica Nad Vahom Slovakia 018 41
    153 Galanta Slovakia
    154 Krompachy Slovakia
    155 Piestany Slovakia
    156 Presov Slovakia
    157 Reading Berkshire United Kingdom RG7 3SQ
    158 Penzance Cornwall United Kingdom
    159 Chesterfield Derbyshire United Kingdom S40 4AA
    160 Poole Dorset United Kingdom
    161 Romford Essex United Kingdom
    162 Blackpool Lancashire United Kingdom
    163 Thornton-cleveleys Lancashire United Kingdom
    164 Wigan Lancashire United Kingdom
    165 Salford Manchester United Kingdom
    166 Southport Merseyside United Kingdom
    167 Wellingborough Northamptonshire United Kingdom NN8 4RW
    168 Barnsley South Yorkshire United Kingdom
    169 Cannock Staffordshire United Kingdom
    170 North Shields Tyne and Wear United Kingdom
    171 Atherstone Warwickshire United Kingdom CV9 1EU
    172 Dudley WEST Midlands United Kingdom
    173 Belfast United Kingdom BT7 2EB
    174 Leeds United Kingdom
    175 Manchester United Kingdom
    176 Torpoint United Kingdom

    Sponsors and Collaborators

    • Daiichi Sankyo, Inc.
    • Syneos Health

    Investigators

    • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT02187159
    Other Study ID Numbers:
    • DS5565-A-E311
    • 2013-005163-10
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daiichi Sankyo, Inc.
    pain
    fibromyalgia
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes
    Pregabalin

    Study Results

    Participant Flow

    Recruitment Details A total of 2280 participants who met all inclusion criteria and no exclusion criteria were enrolled from 19 Nov 2014 to 07 July 2016 at 178 sites. Of the 2280 participants enrolled, 1270 participants were randomized.
    Pre-assignment Detail Eligible participants were randomized in a 1:1:1:1 ratio to either DS5565 15 mg QD, DS5565 15 mg BID, placebo, or pregabalin 150 mg BID.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Period Title: Overall Study
    STARTED 318 317 318 317
    COMPLETED 249 238 241 221
    NOT COMPLETED 69 79 77 96

    Baseline Characteristics

    Arm/Group Title Placebo Pregabalin DS-5565 QD DS-5565 BID Total
    Arm/Group Description Participants take one each of placebo tablet and capsule BID) Participants take one pregabalin capsule and one placebo tablet BID Participants 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 Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID) Total of all reporting groups
    Overall Participants 318 317 318 317 1270
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    289
    90.9%
    287
    90.5%
    286
    89.9%
    284
    89.6%
    1146
    90.2%
    >=65 years
    29
    9.1%
    30
    9.5%
    32
    10.1%
    33
    10.4%
    124
    9.8%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50.2
    (11.43)
    50.9
    (11.58)
    50.2
    (11.85)
    50.6
    (11.46)
    50.5
    (11.57)
    Sex: Female, Male (Count of Participants)
    Female
    290
    91.2%
    288
    90.9%
    295
    92.8%
    287
    90.5%
    1160
    91.3%
    Male
    28
    8.8%
    29
    9.1%
    23
    7.2%
    30
    9.5%
    110
    8.7%
    Region of Enrollment (Count of Participants)
    New Zealand
    7
    2.2%
    8
    2.5%
    8
    2.5%
    10
    3.2%
    33
    2.6%
    Latvia
    7
    2.2%
    9
    2.8%
    6
    1.9%
    10
    3.2%
    32
    2.5%
    Romania
    9
    2.8%
    11
    3.5%
    6
    1.9%
    5
    1.6%
    31
    2.4%
    Hungary
    5
    1.6%
    7
    2.2%
    6
    1.9%
    7
    2.2%
    25
    2%
    United States
    188
    59.1%
    188
    59.3%
    188
    59.1%
    188
    59.3%
    752
    59.2%
    United Kingdom
    39
    12.3%
    38
    12%
    38
    11.9%
    38
    12%
    153
    12%
    Slovakia
    14
    4.4%
    7
    2.2%
    9
    2.8%
    11
    3.5%
    41
    3.2%
    Australia
    5
    1.6%
    5
    1.6%
    5
    1.6%
    5
    1.6%
    20
    1.6%
    Bulgaria
    16
    5%
    19
    6%
    22
    6.9%
    17
    5.4%
    74
    5.8%
    Estonia
    6
    1.9%
    5
    1.6%
    6
    1.9%
    4
    1.3%
    21
    1.7%
    India
    12
    3.8%
    11
    3.5%
    12
    3.8%
    9
    2.8%
    44
    3.5%
    Russia
    7
    2.2%
    8
    2.5%
    12
    3.8%
    12
    3.8%
    39
    3.1%
    Lithuania
    3
    0.9%
    1
    0.3%
    0
    0%
    1
    0.3%
    5
    0.4%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    ADPS was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 311 315 313
    Mean (Standard Error) [units on a scale]
    -1.86
    (0.130)
    -2.47
    (0.133)
    -2.24
    (0.133)
    -2.09
    (0.134)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.61
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.183
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0392
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.38
    Confidence Interval (2-Sided) 95%
    -0.74 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.183
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2192
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.23
    Confidence Interval (2-Sided) 95%
    -0.58 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.183
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2095
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.23
    Confidence Interval (2-Sided) 95%
    -0.13 to 0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.184
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0381
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.38
    Confidence Interval (2-Sided) 95%
    0.02 to 0.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.185
    Estimation Comments
    2. Secondary Outcome
    Title Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" (≤2 scores) are reported.
    Time Frame Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    PGIC was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Count of Participants [Participants]
    91
    28.6%
    141
    44.5%
    116
    36.5%
    117
    36.9%
    3. Secondary Outcome
    Title Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome. For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    FIQ was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 313 312 312 312
    Mean (Standard Deviation) [units on a scale]
    -13.88
    (1.20)
    -21.46
    (1.22)
    -17.41
    (1.22)
    -16.45
    (1.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.67
    Confidence Interval (2-Sided) 95%
    -10.71 to -4.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.598
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0289
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.52
    Confidence Interval (2-Sided) 95%
    -6.68 to -0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.613
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1148
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.56
    Confidence Interval (2-Sided) 95%
    -5.75 to 0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.625
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0125
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.05
    Confidence Interval (2-Sided) 95%
    0.87 to 7.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.621
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Analysis was based on multiple imputation and pattern mixture model with delta shifting.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments
    Method Difference of means
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.01
    Confidence Interval (2-Sided) 95%
    1.78 to 8.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.647
    Estimation Comments
    4. Secondary Outcome
    Title Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.
    Time Frame Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    Responder rates were assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    30% Responders
    113
    35.5%
    139
    43.8%
    123
    38.7%
    118
    37.2%
    50% Responders
    61
    19.2%
    90
    28.4%
    79
    24.8%
    68
    21.5%
    5. Secondary Outcome
    Title Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue). For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    Multidimensional Fatigue Inventory (MFI-20) was assessed in the modified intent-to-treat (mITT) population.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 293 294 295 291
    Mean (Standard Deviation) [units on a scale]
    -1.4
    (3.45)
    -2.8
    (3.99)
    -2.3
    (3.57)
    -2.1
    (3.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -1.8 to -0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0247
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.2 to -0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0411
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.1 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0352
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    0.0 to 1.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0214
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    0.1 to 1.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    HADS was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Change from baseline to Week 13: Anxiety
    -0.5
    (3.43)
    -1.4
    (3.47)
    -0.7
    (3.30)
    -0.8
    (3.31)
    Change from baseline to Week 13: Depression
    -0.8
    (3.66)
    -1.6
    (3.86)
    -1.1
    (3.78)
    -0.8
    (3.83)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Anxiety: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.5 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Anxiety: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5066
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Anxiety: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1462
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    0.3 to 1.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0338
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    0.0 to 1.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Depression: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0116
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.3 to -0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Depression: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7085
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Depression: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9392
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0311
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    0.1 to 1.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0094
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    0.2 to 1.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 scale ranges from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) scores are reported.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    This outcome was assessed using the modified intent-to-treat analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Change from baseline to Week 13:Physical Component
    4.395
    (6.81)
    5.815
    (8.03)
    5.000
    (7.76)
    4.833
    (7.18)
    Change from baseline to Week 13: Mental Component
    1.371
    (9.43)
    3.093
    (8.93)
    1.675
    (9.94)
    1.198
    (8.37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Physical Component: Placebo vs Pregabalin
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0373
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 1.256
    Confidence Interval (2-Sided) 95%
    0.074 to 2.439
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6027
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Physical Component: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5458
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value 0.364
    Confidence Interval (2-Sided) 95%
    -0.817 to 1.545
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6020
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Physical Component: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6968
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.235
    Confidence Interval (2-Sided) 95%
    -0.949 to 1.420
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6038
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Physical Component: Pregabalin vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1379
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.893
    Confidence Interval (2-Sided) 95%
    -2.073 to 0.287
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6014
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Physical Component: Pregabalin vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0908
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -1.021
    Confidence Interval (2-Sided) 95%
    -2.205 to 0.163
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6033
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Mental Component: Placebo vs Pregabalin
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0068
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 1.890
    Confidence Interval (2-Sided) 95%
    0.523 to 3.256
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6965
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Mental Component: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5594
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.406
    Confidence Interval (2-Sided) 95%
    -0.959 to 1.771
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6956
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Mental Component: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9736
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.023
    Confidence Interval (2-Sided) 95%
    -1.346 to 1.392
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6979
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Mental Component: Pregabalin vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0331
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -1.484
    Confidence Interval (2-Sided) 95%
    -2.848 to -0.119
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6953
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Mental Component: Pregabalin vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0076
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -1.867
    Confidence Interval (2-Sided) 95%
    -3.235 to -0.498
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6976
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome. For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    The EQ-5D was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 293 292 295 291
    Mean (Standard Deviation) [units on a scale]
    0.060
    (0.18)
    0.10
    (0.19)
    0.08
    (0.17)
    0.07
    (0.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0201
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.0309
    Confidence Interval (2-Sided) 95%
    0.0048 to 0.0570
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.01328
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1798
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value 0.0178
    Confidence Interval (2-Sided) 95%
    -0.0082 to 0.0438
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.01324
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5922
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value 0.0071
    Confidence Interval (2-Sided) 95%
    -0.0189 to 0.0332
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.01329
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3221
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.0131
    Confidence Interval (2-Sided) 95%
    -0.0392 to 0.0129
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.01326
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0739
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.0238
    Confidence Interval (2-Sided) 95%
    -0.0499 to 0.0023
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.01330
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    Pain-associated sleep interference was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Least Squares Mean (Standard Error) [units on a scale]
    -1.92
    (0.11)
    -2.41
    (0.11)
    -2.48
    (0.11)
    -2.44
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.49
    Confidence Interval (2-Sided) 95%
    -0.79 to -0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.153
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.56
    Confidence Interval (2-Sided) 95%
    -0.86 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.153
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -0.81 to -0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.153
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6464
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.07
    Confidence Interval (2-Sided) 95%
    -0.37 to 0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.154
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8543
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.03
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.154
    Estimation Comments
    10. Secondary Outcome
    Title The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).
    Time Frame Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    The MOS sleep scale outcome was assessed in the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Count of Participants [Participants]
    90
    28.3%
    94
    29.7%
    101
    31.8%
    106
    33.4%
    11. Secondary Outcome
    Title Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.
    Time Frame Baseline up to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    BFI-SF was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Worst pain
    -1.7
    (2.36)
    -2.6
    (2.37)
    -2.2
    (2.55)
    -2.1
    (2.30)
    Least pain
    -1.4
    (2.53)
    -1.9
    (2.37)
    -1.5
    (2.53)
    -1.6
    (2.25)
    Average pain
    -1.5
    (2.13)
    -2.1
    (2.15)
    -1.8
    (2.15)
    -1.8
    (1.96)
    Pain right now
    -1.8
    (2.76)
    -2.8
    (2.48)
    -2.3
    (2.54)
    -2.2
    (2.40)
    Severity score
    -1.59
    (2.17)
    -2.33
    (2.08)
    -1.96
    (2.17)
    -1.91
    (1.95)
    Relief (%) by treatment of pain
    20.1
    (33.69)
    31.1
    (33.15)
    24.2
    (33.26)
    25.9
    (35.09)
    Interference (%)
    -14.79
    (22.33)
    -23.76
    (21.81)
    -19.97
    (23.37)
    -18.35
    (20.68)
    General activity
    -1.6
    (2.77)
    -2.5
    (2.63)
    -2.1
    (2.66)
    -2.1
    (2.53)
    Mood
    -1.3
    (2.84)
    -2.2
    (2.65)
    -1.6
    (2.94)
    -1.6
    (2.65)
    Walking ability
    -1.5
    (2.60)
    -2.1
    (2.79)
    -1.8
    (2.88)
    -1.4
    (2.60)
    Normal work
    -1.6
    (2.65)
    -2.3
    (2.70)
    -1.9
    (2.77)
    -1.9
    (2.60)
    Relations with other people
    -1.2
    (2.92)
    -1.8
    (2.92)
    -1.6
    (3.12)
    -1.2
    (2.85)
    Sleep
    -1.9
    (2.99)
    -3.3
    (2.83)
    -3.1
    (3.14)
    -3.0
    (2.80)
    Enjoyment of life
    -1.3
    (3.00)
    -2.4
    (2.85)
    -1.9
    (3.22)
    -1.7
    (2.98)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Worst pain: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.0 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Worst pain: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1285
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference of least squares means
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Worst pain: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6595
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0938
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    0.1 to 0.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Least pain: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0235
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to -0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Least pain: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3652
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Least pain: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6885
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.4 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1726
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0627
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.0 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Average pain: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.8 to -0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Average pain: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1362
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Average pain: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4344
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.4 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1264
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0260
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    0.0 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Pain right now: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.1 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Pain right now: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0597
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Pain right now: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1198
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Severity score: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.563
    Confidence Interval (2-Sided) 95%
    -0.885 to -0.240
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1644
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Severity score: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1118
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.261
    Confidence Interval (2-Sided) 95%
    -0.583 to 0.061
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1640
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Severity score: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3870
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.142
    Confidence Interval (2-Sided) 95%
    -0.465 to 0.180
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1646
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0633
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.302
    Confidence Interval (2-Sided) 95%
    -0.020 to 0.624
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1642
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0108
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.420
    Confidence Interval (2-Sided) 95%
    0.097 to 0.744
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1647
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 7.5
    Confidence Interval (2-Sided) 95%
    2.7 to 12.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.41
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Relief by treatment of pain: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2188
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 3.0
    Confidence Interval (2-Sided) 95%
    -1.8 to 7.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.41
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Relief by treatment of pain: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0991
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    -0.8 to 8.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.41
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0611
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -4.5
    Confidence Interval (2-Sided) 95%
    -9.2 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.41
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1489
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -8.2 to 1.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.41
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Interference: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -6.04
    Confidence Interval (2-Sided) 95%
    -9.47 to -2.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.751
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Interference: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0193
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -4.09
    Confidence Interval (2-Sided) 95%
    -7.52 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.747
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Interference: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3506
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -1.64
    Confidence Interval (2-Sided) 95%
    -5.07 to 1.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.752
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2660
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 1.94
    Confidence Interval (2-Sided) 95%
    -1.48 to 5.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.748
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0122
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 4.40
    Confidence Interval (2-Sided) 95%
    0.96 to 7.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.754
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments General activity: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0119
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments General activity: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0659
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments General activity: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5104
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4934
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.3 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0634
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.0 to 0.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Mood: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.1 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Mood: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0837
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Mood: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2379
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0980
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0283
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    0.0 to 0.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Walking ability: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2179
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Walking ability: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6683
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Walking ability: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2247
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.2 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4198
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.2 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0146
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    0.1 to 0.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Normal work: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0662
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Normal work: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2282
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Normal work: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7336
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5240
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.3 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1349
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Relations with other people: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0464
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Relations with other people: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0975
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Relations with other people: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6088
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.3 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7341
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.3 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0125
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    0.1 to 0.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Sleep: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.4 to -0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Sleep: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.3 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Sleep: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.1 to -0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5801
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.3 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1869
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments Enjoyment of life: Placebo vs Pregabalin 150 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.3 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments Enjoyment of life: Placebo vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0271
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments Enjoyment of life: Placebo vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1123
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1183
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.1 to 0.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0299
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    0.0 to 0.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    12. Secondary Outcome
    Title Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo
    Description Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).
    Time Frame Week 1 to Week 13 postdose

    Outcome Measure Data

    Analysis Population Description
    Rescue medication usage was assessed using the modified intent-to-treat (mITT) analysis set.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    Measure Participants 315 312 315 313
    Mean (Standard Deviation) [proportion of days]
    0.23
    (0.32)
    0.21
    (0.31)
    0.22
    (0.32)
    0.21
    (0.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5578
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.015
    Confidence Interval (2-Sided) 95%
    -0.063 to 0.034
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0249
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7034
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.009
    Confidence Interval (2-Sided) 95%
    -0.058 to 0.039
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0248
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4143
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.020
    Confidence Interval (2-Sided) 95%
    -0.069 to 0.028
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0249
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8365
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value 0.005
    Confidence Interval (2-Sided) 95%
    -0.044 to 0.054
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0249
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pregabalin 150 mg BID, DS-5565 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8189
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares means
    Estimated Value -0.006
    Confidence Interval (2-Sided) 95%
    -0.055 to 0.043
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0249
    Estimation Comments

    Adverse Events

    Time Frame Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months.
    Adverse Event Reporting Description A TEAE is any adverse event that emerges 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 (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
    Arm/Group Title Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Arm/Group Description Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID). Participants who received oral pregabalin 150 mg twice daily (BID). Participants who received oral DS5565 15 mg once daily (QD). Participants who received DS-5565 15 mg twice daily (BID).
    All Cause Mortality
    Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Serious Adverse Events
    Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/315 (1.9%) 5/312 (1.6%) 7/315 (2.2%) 11/313 (3.5%)
    Cardiac disorders
    Cardiomegaly 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Supraventricular tachycardia 0/315 (0%) 1/312 (0.3%) 0/315 (0%) 0/313 (0%)
    Eye disorders
    Papilloedema 0/315 (0%) 1/312 (0.3%) 0/315 (0%) 0/313 (0%)
    Gastrointestinal disorders
    Abdominal hernia 1/315 (0.3%) 0/312 (0%) 0/315 (0%) 0/313 (0%)
    General disorders
    Non-cardiac chest pain 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Hepatobiliary disorders
    Biliary colic 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Liver injury 0/315 (0%) 1/312 (0.3%) 0/315 (0%) 0/313 (0%)
    Infections and infestations
    Pneumonia 0/315 (0%) 1/312 (0.3%) 0/315 (0%) 0/313 (0%)
    Injury, poisoning and procedural complications
    Upper limb fracture 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Ankle fracture 0/315 (0%) 1/312 (0.3%) 0/315 (0%) 0/313 (0%)
    Investigations
    Aspartate aminotransferase increased 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Liver function test abnormal 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Transaminases increased 0/315 (0%) 1/312 (0.3%) 0/315 (0%) 0/313 (0%)
    Metabolism and nutrition disorders
    Diabetes mellitus 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Hyperglycaemia 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 1/315 (0.3%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Fibromyalgia 1/315 (0.3%) 0/312 (0%) 0/315 (0%) 0/313 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lip squamous cell carcinoma 1/315 (0.3%) 0/312 (0%) 0/315 (0%) 0/313 (0%)
    Nervous system disorders
    Headache 1/315 (0.3%) 0/312 (0%) 0/315 (0%) 0/313 (0%)
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Psychiatric disorders
    Suicidal ideation 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 2/313 (0.6%)
    Mania 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Suicide attempt 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/315 (0%) 0/312 (0%) 1/315 (0.3%) 0/313 (0%)
    Haemoptysis 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Alveolitis allergic 1/315 (0.3%) 0/312 (0%) 0/315 (0%) 0/313 (0%)
    Vascular disorders
    Haematoma 0/315 (0%) 0/312 (0%) 0/315 (0%) 1/313 (0.3%)
    Other (Not Including Serious) Adverse Events
    Placebo Pregabalin 150 mg BID DS-5565 15 mg QD DS-5565 15 mg BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 206/315 (65.4%) 299/312 (95.8%) 290/315 (92.1%) 242/313 (77.3%)
    Eye disorders
    Vision blurred 5/315 (1.6%) 14/312 (4.5%) 16/315 (5.1%) 13/313 (4.2%)
    Gastrointestinal disorders
    Nausea 14/315 (4.4%) 10/312 (3.2%) 18/315 (5.7%) 28/313 (8.9%)
    Diarrhoea 15/315 (4.8%) 15/312 (4.8%) 20/315 (6.3%) 14/313 (4.5%)
    General disorders
    Drug withdrawal syndrome 20/315 (6.3%) 32/312 (10.3%) 32/315 (10.2%) 28/313 (8.9%)
    Fatigue 9/315 (2.9%) 11/312 (3.5%) 17/315 (5.4%) 11/313 (3.5%)
    Oedema peripheral 4/315 (1.3%) 10/312 (3.2%) 9/315 (2.9%) 16/313 (5.1%)
    Infections and infestations
    Nasopharyngitis 17/315 (5.4%) 19/312 (6.1%) 17/315 (5.4%) 20/313 (6.4%)
    Urinary tract infection 6/315 (1.9%) 13/312 (4.2%) 11/315 (3.5%) 17/313 (5.4%)
    Investigations
    Weight increased 9/315 (2.9%) 39/312 (12.5%) 17/315 (5.4%) 33/313 (10.5%)
    Musculoskeletal and connective tissue disorders
    Fibromyalgia 17/315 (5.4%) 15/312 (4.8%) 10/315 (3.2%) 16/313 (5.1%)
    Back pain 17/315 (5.4%) 8/312 (2.6%) 12/315 (3.8%) 11/313 (3.5%)
    Nervous system disorders
    Headache 40/315 (12.7%) 37/312 (11.9%) 44/315 (14%) 45/313 (14.4%)
    Dizziness 23/315 (7.3%) 47/312 (15.1%) 44/315 (14%) 41/313 (13.1%)
    Somnolence 10/315 (3.2%) 29/312 (9.3%) 23/315 (7.3%) 29/313 (9.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Daiichi Sankyo US Contact for Clinical Trial Results
    Organization Daiichi Sankyo, Inc.
    Phone 1-908-992-6400
    Email CTRinfo@DSI.com
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT02187159
    Other Study ID Numbers:
    • DS5565-A-E311
    • 2013-005163-10
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020