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    Clinical Trial Results:
    A Phase 3 double-blind, randomized, placebo-controlled, safety and efficacy study of once daily controlled release pregabalin in the treatment of patients with postherpetic neuralgia.

    Summary
    EudraCT number
    		 2009-016766-86
    Trial protocol
    		 CZ   SE   SK   BG   DE   HU   DK   PL   HR  
    Global end of trial date
    03 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2016
    First version publication date
    06 Mar 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A0081224
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01270828
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc
    Sponsor organisation address
    235 E 42nd St,, New York,, United States,
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc.,, Pfizer, Inc., 011 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc.,, Pfizer, Inc., ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of pregabalin CR compared with placebo in the durability of effect for the treatment of pain associated with PHN among patients who initially respond to single blind pregabalin. The secondary objectives were to evaluate the efficacy of pregabalin CR compared with placebo to relieve pain and to improve global assessment, functional status, and sleep; to assess treatment satisfaction with pregabalin CR compared with placebo; and to assess the safety and tolerability of the pregabalin CR formulation.
    Protection of trial subjects
    The study was conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidance for Good Clinical Practice (International Conference on Harmonization [ICH] 1996), and the Declaration of Helsinki (World Medical Association 2008). In addition, the study was conducted in accordance with the protocol, the ICH Guideline on Good Clinical Practice (GCP), and applicable local regulatory requirements and laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 8
    Country: Number of subjects enrolled
    Bulgaria: 41
    Country: Number of subjects enrolled
    Croatia: 7
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    India: 16
    Country: Number of subjects enrolled
    Poland: 21
    Country: Number of subjects enrolled
    Russian Federation: 91
    Country: Number of subjects enrolled
    Serbia: 6
    Country: Number of subjects enrolled
    Slovakia: 14
    Country: Number of subjects enrolled
    South Africa: 74
    Country: Number of subjects enrolled
    Sweden: 35
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Ukraine: 91
    Country: Number of subjects enrolled
    United States: 382
    Worldwide total number of subjects
    806
    EEA total number of subjects
    128
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    382
    From 65 to 84 years
    402
    85 years and over
    22

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 129 centers in 17 countries screened participants for the study, including 68 in the US, 6 in Bulgaria, 6 in Poland, 6 in Russia, 6 in the Ukraine, 5 in India, 5 in South Africa, 5 in Sweden, 4 in Slovakia, 3 in Colombia, 3 in Croatia, 3 in Germany, 2 in Denmark, 2 in Hong Kong, 2 in Serbia, 2 in Taiwan, and 1 in the Czech Republic.

    Pre-assignment
    Screening details
    		 The study consisted of 4 phases: Baseline (1 week [wk]): to determine study entry criteria; Single Blind (SB) (6 wks): to determine optimized dose; Double Blind (DB) (13 wks): responders with at least 50% improvement in pain at SB were considered and randomized to pregabalin or matching placebo; and DB taper phase (1 wk).

    Period 1
    Period 1 title
    Pregabalin CR SB (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 Pregabalin CR SB
    Arm description
    		 SB The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin CR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin CR tablets (82.5 mg-660 mg) were taken for the duration of the single blind for 6 weeks (four weeks dose adjustment, 2 weeks stable dose)

    Number of subjects in period 1
    		Pregabalin CR SB
    Started
    806
    Completed
    660
    Not completed
    146
         Unrelated AE
    8
         Consent withdrawn by subject
    29
         Unspecified
    8
         Related adverse event (AE)
    46
         Lost to follow-up
    10
         Enrolled but not treated
    5
         Lack of efficacy
    32
         Protocol deviation
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin CR SB
    Reporting group description
    		 -

    Reporting group values
    		 Pregabalin CR SB Total
    Number of subjects
    		 806 806
    Age categorical
    Units: Subjects
        <18 years
    		 0 0
        18-44 years
    		 82 82
        45-64 years
    		 300 300
        ≥65 years
    		 424 424
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.5 ( 13.7 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 458 458
        Male
    		 348 348

    End points

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    End points reporting groups
    Reporting group title
    Pregabalin CR SB
    Reporting group description
    		 SB The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.

    Subject analysis set title
    Pregabalin CR DB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.

    Subject analysis set title
    Placebo DB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received matching placebo

    Primary: Number of participants with loss of therapeutic response.

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    End point title
    		 Number of participants with loss of therapeutic response.
    End point description
    Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.
    End point type
    Primary
    End point timeframe
    13 Weeks
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    208
    205
    Units: Participants
    29
    63
    Statistical analysis title
    		 Statistical Analysis for participants with LTR
    Statistical analysis description
    Kaplan-Meier method was used for the analysis.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Secondary: Participants with secondary LTR based on 5 day rolling average diary results

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    End point title
    		 Participants with secondary LTR based on 5 day rolling average diary results
    End point description
    A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as: 1. At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score 2. A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.
    End point type
    Secondary
    End point timeframe
    13 Weeks
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    208
    205
    Units: Participants
    49
    87
    Statistical analysis title
    		 Analysis for participants with secondary LTR
    Statistical analysis description
    Kaplan-Meier method was used for the analysis.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Secondary: Percentage of participants with 30% reduction in the mean pain score.

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    End point title
    		 Percentage of participants with 30% reduction in the mean pain score.
    End point description
    The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.
    End point type
    Secondary
    End point timeframe
    13 Weeks
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    206
    204
    Units: Percentage of participants
        number (not applicable)
    95.6
    83.8
    Statistical analysis title
    		 Analysis for 30% reduction in mean pain score
    Statistical analysis description
    Chi-square test was used for analysis.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of participants with 50% reduction in the mean pain score.

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    End point title
    		 Percentage of participants with 50% reduction in the mean pain score.
    End point description
    The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.
    End point type
    Secondary
    End point timeframe
    13 Weeks
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    206
    204
    Units: Percentage of participants
        number (not applicable)
    88.3
    68.6
    Statistical analysis title
    		 Analysis for 50% reduction in mean pain score
    Statistical analysis description
    Chi-square test was used for analysis.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Change from Baseline to endpoint in weekly mean pain score.

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    End point title
    		 Change from Baseline to endpoint in weekly mean pain score.
    End point description
    The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain
    End point type
    Secondary
    End point timeframe
    SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    206
    205
    Units: Units on a scale
    least squares mean (standard error)
        SB Baseline to Week 19
    -4.89 ( 0.12 )
    -3.95 ( 0.12 )
        DB Baseline to Week 19
    -0.04 ( 0.11 )
    0.87 ( 0.11 )
    Statistical analysis title
    		 Analysis from SB BL to Week 19-mean pain score
    Statistical analysis description
    This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Analysis from DB BL to Week 19-mean pain score
    Statistical analysis description
    This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 -0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Change in the Weekly NRS-Pain (1-Week Recall).

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    End point title
    		 Change in the Weekly NRS-Pain (1-Week Recall).
    End point description
    The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.
    End point type
    Secondary
    End point timeframe
    SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    195
    Units: Units on a scale
    least squares mean (standard error)
        SB Baseline to Week 19
    -5 ( 0.13 )
    -3.9 ( 0.14 )
        DB Baseline to Week 19
    -0.1 ( 0.13 )
    0.9 ( 0.13 )
    Statistical analysis title
    		 Analysis from SB BL to Week 19 for NRS-Pain
    Statistical analysis description
    This ANCOVA model analysis is for SB Baseline (BL) to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 -0.75
    Statistical analysis title
    		 Analysis from DB BL to Week 19 for NRS-Pain
    Statistical analysis description
    This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 -0.65

    Secondary: Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).

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    End point title
    		 Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).
    End point description
    The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
    End point type
    Secondary
    End point timeframe
    SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    195
    Units: Units on a scale
    least squares mean (standard error)
        Sleep Problems Index I-SB BL to wk 19(N=202,195)
    -19.9 ( 1.09 )
    -16.7 ( 1.13 )
        Sleep Problems Index I-DB BL to wk 19(N=202,195)
    1.2 ( 1.05 )
    4.4 ( 1.09 )
        SleepProblems Index II-SB BL to wk 19(N=202,195)
    -21.2 ( 1.07 )
    -17.4 ( 1.11 )
        SleepProblems Index II-DB BL to wk 19(N=202,194)
    0.2 ( 1.01 )
    4.3 ( 1.05 )
        Sleep Disturbance-SB BL to wk 19
    -28.31 ( 1.42 )
    -21.1 ( 1.48 )
        Sleep Disturbance-DB BL to wk 19
    -1.1 ( 1.31 )
    7.6 ( 1.36 )
        Snoring-SB BL to wk 19(N=202,194)
    -3.3 ( 1.57 )
    -4.7 ( 1.64 )
        Snoring-DB BL to wk 19(N=201,194)
    -0.6 ( 1.41 )
    0.8 ( 1.46 )
        Awaken short of breath/headache-SB BL to wk 19
    -11.9 ( 1.21 )
    -10.4 ( 1.26 )
        Awaken short of breath/headache-DB BL to wk 19
    -1.2 ( 1.23 )
    -0.2 ( 1.27 )
        Sleep adequacy-SB BL to wk 19
    19.9 ( 1.83 )
    17.5 ( 1.9 )
        Sleep adequacy-DB BL to wk 19(N=202,195)
    -3.3 ( 1.82 )
    -6 ( 1.89 )
        Somnolence-SB BL to wk 19(N=202,195)
    -12 ( 1.19 )
    -12 ( 1.23 )
        Somnolence-DB BL to wk 19(N=203,194)
    -0.7 ( 1.15 )
    -0.9 ( 1.19 )
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0324
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 -0.3
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0223
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 -0.5
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0098
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 -0.9
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0033
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 -1.4
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 -3.5
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 -5.2
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5264
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 5.6
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.452
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 2.3
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3714
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 1.8
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5639
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 2.3
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3223
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 7.3
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2742
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 7.6
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9816
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 3.1
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9282
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 3.2

    Secondary: Change in the MOS-SS-Quantity of sleep.

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    End point title
    		 Change in the MOS-SS-Quantity of sleep.
    End point description
    The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. The item "Quantity of sleep" of MOS-SS is presented here.
    End point type
    Secondary
    End point timeframe
    SB BL (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    192
    Units: Hours
    least squares mean (standard error)
        Quantity of sleep-SB BL to wk 19(N=203,192)
    0.9 ( 0.09 )
    0.7 ( 0.1 )
        Quantity of sleep-DB BL to wk 19(N=202,192)
    -0.1 ( 0.08 )
    -0.4 ( 0.09 )
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    395
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1635
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.4
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    395
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0363
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.5

    Secondary: The MOS-SS-Optimal Sleep.

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    End point title
    		 The MOS-SS-Optimal Sleep.
    End point description
    The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The "percentage of participants with optimal sleep" is presented here.
    End point type
    Secondary
    End point timeframe
    Week 6 and Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    208
    205
    Units: Percentage of participants
    number (not applicable)
        Week 6 (N=208,205)
    58.7
    62.4
        Week 19 (N=204,197)
    54.9
    54.8
    Statistical analysis title
    		 Statistical Analysis for Week 6 Optimal sleep
    Statistical analysis description
    This analysis is for Week 6
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.432
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis for Week 19 Optimal sleep
    Statistical analysis description
    This analysis is for Week 19
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.987
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Number of participants with change in the Patient Global Impression of Change (PGIC) score

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    End point title
    		 Number of participants with change in the Patient Global Impression of Change (PGIC) score
    End point description
    The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.
    End point type
    Secondary
    End point timeframe
    Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    195
    Units: Participants
        Very much improved
    64
    45
        Much improved
    75
    59
        Minimally improved
    34
    37
        No change
    21
    25
        Minimally worse
    5
    14
        Much worse
    3
    14
        Very much worse
    1
    1
    Statistical analysis title
    		 Statistical Analysis for PGIC original score
    Statistical analysis description
    This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 2.65
    Statistical analysis title
    		 Statistical Analysis for PGIC categorized score
    Statistical analysis description
    This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0009
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 3.81

    Secondary: Change in the Short Form 36 Health Survey (SF-36)

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    End point title
    		 Change in the Short Form 36 Health Survey (SF-36)
    End point description
    The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. Higher scores indicate a better health related quality of life. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.
    End point type
    Secondary
    End point timeframe
    Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    195
    Units: Units on a scale
    least squares mean (standard error)
        Physical Component-SB BL to wk 19(N=202,195)
    7.5 ( 0.54 )
    5.6 ( 0.56 )
        Physical Component-DB BL to wk 19(N=202,195)
    0.1 ( 0.51 )
    -2.3 ( 0.53 )
        Mental Component-SB BL to wk 19(N=202,195)
    6.4 ( 0.62 )
    5.5 ( 0.64 )
        Mental Component-DB BL to wk 19(N=202,195)
    -1.1 ( 0.62 )
    -2.2 ( 0.64 )
        Physical functioning-SB BL to wk 19
    11.7 ( 1.44 )
    8.9 ( 1.49 )
        Physical functioning-DB BL to wk 19
    -1.4 ( 1.25 )
    -4.9 ( 1.29 )
        Role-Physical-SB BL to wk 19
    18.9 ( 1.62 )
    13.9 ( 1.67 )
        Role-Physical-DB BL to wk 19
    -2.4 ( 1.54 )
    -7.7 ( 1.6 )
        Bodily pain-SB BL to wk 19
    31 ( 1.51 )
    23.6 ( 1.56 )
        Bodily pain-DB BL to wk 19
    1.4 ( 1.38 )
    -6.2 ( 1.43 )
        General HealthPerception-SB BL to wk19(N=202,195)
    11.3 ( 1.05 )
    8.2 ( 1.08 )
        General HealthPerception-DB BL to wk19(N=202,195)
    1.4 ( 0.96 )
    -4 ( 1 )
        Vitality-SB BL to wk 19(N=202,195)
    13.7 ( 1.25 )
    10.7 ( 1.3 )
        Vitality-DB BL to wk 19(N=202,195)
    -3.5 ( 1.21 )
    -6.5 ( 1.25 )
        Social Functioning-SB BL to wk 19
    18.5 ( 1.35 )
    15.7 ( 1.39 )
        Social Functioning-DB BL to wk 19
    -2.1 ( 1.28 )
    -4.3 ( 1.32 )
        Role-Emotional-SB BL to wk 19
    15 ( 1.43 )
    11.6 ( 1.47 )
        Role-Emotional-DB BL to wk 19
    -1.4 ( 1.42 )
    -5.4 ( 1.47 )
        Mental Health-SB BL to wk 19(N=202,195)
    11.1 ( 1.05 )
    9.5 ( 1.08 )
        Mental Health-DB BL to wk 19(N=202,195)
    -1.3 ( 1.04 )
    -3.7 ( 1.08 )
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.4
         upper limit
    		 11.5
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4
         upper limit
    		 11.3
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0275
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 6
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 8
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0735
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 6.4
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0684
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 6.2
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1197
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 6.4
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.221
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 5.5
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0847
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 7.1
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0365
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 7.8
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2749
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 4.3
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Mental Health-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0806
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 5.2
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0082
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 3.4
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.7
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2097
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 2.5
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1669
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 2.8
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1466
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 6.7
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0439
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 6.7
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Role-Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 9.3
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Role-Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0107
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 9.5

    Secondary: Change in Mean Daily Sleep Interference scores

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    End point title
    		 Change in Mean Daily Sleep Interference scores
    End point description
    The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.
    End point type
    Secondary
    End point timeframe
    Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    206
    204
    Units: Units on a scale
    least squares mean (standard error)
        SB Baseline to Week 19 (N=205,203)
    -4.5 ( 0.11 )
    -3.5 ( 0.11 )
        DB Baseline to Week 19 (N=206,204)
    -0.2 ( 0.1 )
    0.7 ( 0.1 )
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 -0.58
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.23
         upper limit
    		 -0.64

    Secondary: Change in Hospital Anxiety and Depression Scales (HADS)

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    End point title
    		 Change in Hospital Anxiety and Depression Scales (HADS)
    End point description
    The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety
    End point type
    Secondary
    End point timeframe
    Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    195
    Units: Units on a scale
    least squares mean (standard error)
        HADS-Anxiety-SB Baseline to Week 19
    -1.8 ( 0.21 )
    -1.1 ( 0.21 )
        HADS-Anxiety-DB Baseline to Week 19
    0.1 ( 0.19 )
    0.9 ( 0.2 )
        HADS-Depression-SB Baseline to Week 19
    -1.8 ( 0.2 )
    -1.2 ( 0.21 )
        HADS-Depression-DB Baseline to Week 19
    0.2 ( 0.19 )
    0.8 ( 0.19 )
    Statistical analysis title
    		 Analysis from SB Baseline to Week 19 for Anxiety
    Statistical analysis description
    This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0154
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.1
    Statistical analysis title
    		 Analysis from DB Baseline to Week 19 for Anxiety
    Statistical analysis description
    This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0027
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.3
    Statistical analysis title
    		 Analysis from SB Baseline to wk 19 for Depression
    Statistical analysis description
    This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0166
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.1
    Statistical analysis title
    		 Analysis from DB Baseline to wk 19 for Depression
    Statistical analysis description
    This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0217
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.1

    Secondary: Change in the Brief Pain Inventory (BPI-sf)

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    End point title
    		 Change in the Brief Pain Inventory (BPI-sf)
    End point description
    The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).
    End point type
    Secondary
    End point timeframe
    Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    203
    195
    Units: Units on a scale
    least squares mean (standard error)
        Pain Severity Index-SB Baseline to Week 19
    -18 ( 0.47 )
    -13.8 ( 0.49 )
        Pain Severity Index-DB Baseline to Week 19
    -0.7 ( 0.43 )
    3.1 ( 0.44 )
        Pain Interference Index-SB Baseline to Week 19
    -21.9 ( 0.71 )
    -17.2 ( 0.74 )
        Pain Interference Index-DB Baseline to Week 19
    -0.2 ( 0.67 )
    4 ( 0.7 )
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 -3
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 -2.7
    Statistical analysis title
    		 Analysis from SB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 -2.7
    Statistical analysis title
    		 Analysis from DB BL to Week 19
    Statistical analysis description
    This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 -2.4

    Secondary: Percentage of participants with benefit from treatment, satisfaction with treatment and willingness to continue treatement (BSW)

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    End point title
    		 Percentage of participants with benefit from treatment, satisfaction with treatment and willingness to continue treatement (BSW)
    End point description
    The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.
    End point type
    Secondary
    End point timeframe
    Week 19
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    201
    193
    Units: Percentage of participants
    number (not applicable)
        Benefit from treatment
    98.5
    93.3
        Satisfaction with treatment
    96
    90.7
        Willingness to continue treatment
    87.6
    81.3
    Statistical analysis title
    		 Statistical Analysis for 'Benefit from treatment'
    Statistical analysis description
    This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0161
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 17
    Statistical analysis title
    		 Analysis for 'Satisfaction with treatment'
    Statistical analysis description
    This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0378
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 5.85
    Statistical analysis title
    		 Analysis for 'Willingness to continue treatment'
    Statistical analysis description
    This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.
    Comparison groups
    Pregabalin CR DB v Placebo DB
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0901
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 2.81

    Secondary: Number of participants with adverse events

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    End point title
    		 Number of participants with adverse events
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective "severe" to those AEs that interfere significantly with participant's usual function.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 20
    End point values
    		 Pregabalin CR SB Pregabalin CR DB Placebo DB
    Number of subjects analysed
    801 [1]
    208
    205
    Units: Participants
        Participants with AEs
    441
    80
    63
        Participants with Serious AEs
    17
    7
    3
        Participants with Severe AEs
    35
    9
    3
    Notes
    [1] - 801 participants were treated
    No statistical analyses for this end point

    Secondary: Percentage of participants with suicidal behaviour/ideation

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    End point title
    		 Percentage of participants with suicidal behaviour/ideation
    End point description
    Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 6, 11, 15, 19 and 20
    End point values
    		 Pregabalin CR DB Placebo DB
    Number of subjects analysed
    208
    205
    Units: Percentage of participants
    number (not applicable)
        SB BL(N=208,205)
    0
    0.5
        Week 6 (N=208,205)
    0
    0
        Week 11 (N=194,178)
    0
    0
        Week 15 (N=183,167)
    0
    0
        Week 19 (N=204,197)
    0
    0
        Week 20 (N=199,194)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 20
    Adverse event reporting additional description
    The SB analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Both SBAS and FAS were included in this analysis.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Pregabalin CR DB
    Reporting group description
    		 Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.

    Reporting group title
    Placebo DB
    Reporting group description
    		 Participants received matching placebo

    Reporting group title
    Pregabalin CR SB
    Reporting group description
    		 The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.

    Serious adverse events
    		 Pregabalin CR DB Placebo DB Pregabalin CR SB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 208 (3.37%)
    3 / 205 (1.46%)
    17 / 801 (2.12%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Sexual abuse
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 205 (0.49%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia of chronic disease
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 205 (0.49%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 205 (0.49%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 205 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pregabalin CR DB Placebo DB Pregabalin CR SB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 208 (3.37%)
    1 / 205 (0.49%)
    202 / 801 (25.22%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 208 (3.37%)
    1 / 205 (0.49%)
    137 / 801 (17.10%)
         occurrences all number
    7
    1
    161
    Somnolence
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 205 (0.00%)
    91 / 801 (11.36%)
         occurrences all number
    1
    0
    104

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2010
    The protocol was amended based on the response received from FDA after request for advice/information. Few of the changes are listed as follows: changes were made in secondary endpoint and information of interim analysis was added. The amendment provided a better understanding of the pharmacokinetic profile.
    11 Nov 2010
    The FDA guidance required monitoring of suicidality in all clinical visits, PK section was clarified, edema was added as assessment as part of the physical exam, and changes were made in document history.
    16 Mar 2011
    Based on the request by the regulatories changes were made. Few of the changes are listed as follows: the protocol synopsis was added, pregnancy as withdrawal criteria was added, change of suicidality assessment from Suicidality Tracking Scale (STS) to Columbia Suicidal Severity Rating Scale (C SSRS) were made.
    18 Dec 2012
    Few of the changes are listed below: The 5 day rolling average during DB, compared to the 5 day randomization baseline pain score was added; medication error are reportable events regardless of whether or not it is accompanied by an AE should be documented; clarification on pregnancy test; and revisions in adverse event sections.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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