Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN (BID) IN SUBJECTS WITH POST TRAUMATIC PERIPHERAL NEUROPATHIC PAIN.

    Summary
    EudraCT number
    		 2012-003304-12
    Trial protocol
    		 DE   DK   BG   HU   BE   HR  
    Global end of trial date
    04 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2016
    First version publication date
    05 Aug 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A0081279
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01701362
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer Clinical Trials.gov Call Center, Pfizer, Inc, 001 18007181021 x, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer Clinical Trials.gov Call Center, Pfizer, Inc, 001 18007181021 x, 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
    04 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of pregabalin (150-600 mg/day) compared with placebo in the treatment of chronic post-traumatic peripheral neuropathic pain.
    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), Guidelines for GCP (ICH 1996), and the Declaration of Helsinki (World Medical Association 1996 & 2008). In addition, the study was conducted in accordance with the protocol, the ICH guideline on GCP, and applicable local regulatory requirements and laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2012
    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
    Bulgaria: 43
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Poland: 41
    Country: Number of subjects enrolled
    Romania: 7
    Country: Number of subjects enrolled
    South Africa: 5
    Country: Number of subjects enrolled
    Sweden: 27
    Country: Number of subjects enrolled
    United States: 362
    Worldwide total number of subjects
    539
    EEA total number of subjects
    163
    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)
    437
    From 65 to 84 years
    101
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 187 centers participated in the study in 14 countries.

    Pre-assignment
    Screening details
    		 Single-blind screening period. Criteria such as chronic neuropathic pain for >6 months post trauma/surgeries as per medical history and not due to other causes like post herpetic neuralgia, trigeminal neuralgia; meeting other criteria for neuropathic pain assessment; and diagnosis of certain psychiatric conditions were considered.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pregabalin
    Arm description
    		 Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Lyrica
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    orally BID, with or without food

    Arm title
    		 Placebo
    Arm description
    		 Participants randomized to receive placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    orally BID, with or without food

    Number of subjects in period 1
    		Pregabalin Placebo
    Started
    274
    265
    Completed
    233
    211
    Not completed
    41
    54
         Adverse events related to study drug
    12
    10
         Adverse event, serious fatal
    -
    1
         Reasons other than those mentioned above
    3
    5
         No longer willing to participate
    8
    14
         Lost to follow-up
    6
    9
         Adverse events not related to study drug
    1
    6
         Protocol deviation
    5
    3
         Insufficient clinical response
    6
    6

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants randomized to receive placebo

    Reporting group values
    		 Pregabalin Placebo Total
    Number of subjects
    		 274 265
    Age, Customized
    Only participants enrolled in the study who received at least one dose of study drug have been included here.
    Units: Participants
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 52.8 ± 12.9 53.4 ± 12.7 -
    Gender, Male/Female
    Only number of participants who enrolled and received at least one dose of study drug have been included here.
    Units: Participants
        Female
    		 132 134 266
        Male
    		 142 131 273

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants randomized to receive placebo

    Primary: Baseline Mean Pain Score

    		 Close Top of page
    End point title
    		 Baseline Mean Pain Score [1]
    End point description
    This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this primary endpoint
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
        arithmetic mean (standard deviation)
    6.41 ± 1.3
    6.54 ± 1.3
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 15 in Weekly Mean Pain Score

    		 Close Top of page
    End point title
    		 Change from Baseline to Week 15 in Weekly Mean Pain Score
    End point description
    This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
    End point type
    Primary
    End point timeframe
    up to Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
        least squares mean (standard error)
    -2.12 ± 0.15
    -1.9 ± 0.16
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    Mixed Model Repeated Measures (MMRM) method used here includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and a fixed continuous effect of baseline value. Missing mean pain scores were imputed by multiple imputation method.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1823
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least squares mean difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Patient Global Impression of Change (PGIC) at Week 15

    		 Close Top of page
    End point title
    		 Patient Global Impression of Change (PGIC) at Week 15
    End point description
    A self administered instrument that measures changes in participants’ overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: proportion of participants
        Very much improved
    52
    41
        Much improved
    105
    79
        Minimally improved
    61
    62
        No change
    34
    51
        Minimally worse
    5
    9
        Much worse
    0
    4
        Very much worse
    1
    0
        MIssing
    0
    3
    Statistical analysis title
    		 PGIC at Week 15
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0012 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.

    Secondary: Change from baseline in overall weekly mean sleep interference score (SIRS)

    		 Close Top of page
    End point title
    		 Change from baseline in overall weekly mean sleep interference score (SIRS)
    End point description
    This is an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.
    End point type
    Secondary
    End point timeframe
    up to Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (raw scores) (N = 274, 265)
    4.97 ± 2.3
    4.99 ± 2.27
        Week 1 (N = 260, 258)
    -0.66 ± 1.1
    -0.28 ± 0.91
        Week 2 (N = 254, 244)
    -1.15 ± 1.51
    -0.81 ± 1.27
        Week 3 (N = 252, 245)
    -1.55 ± 1.73
    -1.14 ± 1.45
        Week 4 (N = 245, 229)
    -1.73 ± 1.8
    -1.3 ± 1.63
        Week 5 (N = 241, 226)
    -1.87 ± 1.87
    -1.4 ± 1.68
        Week 6 (N = 244, 227)
    -1.94 ± 1.95
    -1.46 ± 1.79
        Week 7 (N = 240, 216)
    -2.01 ± 1.99
    -1.5 ± 1.78
        Week 8 (N = 236, 212)
    -2.05 ± 2
    -1.52 ± 1.76
        Week 9 (N = 232, 214)
    -2.09 ± 1.99
    -1.55 ± 1.86
        Week 10 (N = 229, 212)
    -2.04 ± 2.11
    -1.55 ± 1.83
        Week 11 (N = 230, 211)
    -2.09 ± 2.05
    -1.64 ± 1.79
        Week 12 (N = 227, 209)
    -2.17 ± 2.06
    -1.68 ± 1.89
        Week 13 (N = 225, 204)
    -2.19 ± 2.06
    -1.7 ± 1.9
        Week 14 (N = 222, 208)
    -2.19 ± 2.16
    -1.79 ± 1.89
        Week 15 (N = 196, 186)
    -2.13 ± 2.17
    -1.83 ± 1.87
        Overall (N = 269, 262)
    -1.83 ± 1.93
    -1.37 ± 1.71
    Statistical analysis title
    		 Week 1
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0119
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 -0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0135
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 -0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 3
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0028
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 -0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0016
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 -0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 5
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0007
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 6
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0006
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 -0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 7
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0008
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0003
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 -0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 9
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0001
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 10
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.77
         upper limit
    		 -0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 11
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0007
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 12
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0001
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 13
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 -0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 14
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 -0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Week 15
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0031
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 -0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Overall
    Statistical analysis description
    Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0001
    Method
    		 Mixed Model Repeated Measures Analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 -0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Change from baseline in Pain Severity Index (Brief Pain Inventory-short form [BPI-sf])

    		 Close Top of page
    End point title
    		 Change from baseline in Pain Severity Index (Brief Pain Inventory-short form [BPI-sf])
    End point description
    A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 to 10 (“No Pain” to “Pain as bad as you can imagine”).
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
        least squares mean (standard error)
    -2.4 ± 0.13
    -1.95 ± 0.13
    Statistical analysis title
    		 pain severity index: change from Baseline
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    -0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.77
         upper limit
    		 -0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Change from baseline in Pain Interference Index (BPI-sf)

    		 Close Top of page
    End point title
    		 Change from baseline in Pain Interference Index (BPI-sf)
    End point description
    The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and he impact of pain on daily functions. Another item of the pain scale, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 (“Does not interfere” to “Completely interferes").
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
        least squares mean (standard error)
    -1.72 ± 0.13
    -1.33 ± 0.13
    Statistical analysis title
    		 pain interference index: change from baseline
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0168
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Change from baseline to endpoint in quality of life using EuroQol (EQ-5D) health state profile scores

    		 Close Top of page
    End point title
    		 Change from baseline to endpoint in quality of life using EuroQol (EQ-5D) health state profile scores
    End point description
    A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status).
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
    least squares mean (standard error)
        Mobility
    -0.1 ± 0.03
    -0.09 ± 0.03
        Self-care
    -0.08 ± 0.02
    -0.06 ± 0.02
        Usual activities
    -0.12 ± 0.03
    -0.13 ± 0.04
        Pain/Discomfort
    -0.35 ± 0.03
    -0.29 ± 0.04
        Anxiety/Depression
    0.01 ± 0.03
    -0.02 ± 0.03
        Dolan 1997 Index Score
    0.12 ± 0.01
    0.11 ± 0.01
        Dolan 2001 Index Score
    -0.13 ± 0.02
    -0.12 ± 0.02
    Statistical analysis title
    		 Mobility
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6841
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.037
    Statistical analysis title
    		 Self-care
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6564
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.029
    Statistical analysis title
    		 Usual activities
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.859
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.043
    Statistical analysis title
    		 Pain/Discomfort
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1628
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.043
    Statistical analysis title
    		 Anxiety/Depression
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4654
    Method
    		 ANCOVA
    Parameter type
    		 leaset squares mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.037
    Statistical analysis title
    		 Dolan 1997 Index score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Statistical analysis title
    		 Dolan 2001 Index Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5493
    Method
    		 ANCOVA
    Parameter type
    		 leaset squares mean difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.026

    Secondary: Mean baseline scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.

    		 Close Top of page
    End point title
    		 Mean baseline scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
    End point description
    The Baseline scores for the self-administered measure consisting of twelve items that assess the key constructs of sleep. Subjects are asked to recall sleep-related activities over the past week. Instrument scoring results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: units on a scale
    arithmetic mean (standard deviation)
        Sleep Disturbance Score (N = 274, 265)
    46.04 ± 25.791
    45.33 ± 25.08
        Sleep Adequancy Score (N = 274, 265)
    46.57 ± 28.153
    44.23 ± 28.582
        Snoring Score (N = 272, 263)
    33.09 ± 33.482
    35.89 ± 34.084
        Awaken Short of Breath Score (N = 274, 265)
    16.79 ± 25.647
    13.89 ± 21.541
        Quantity of Sleep Score (hours) (N = 273, 265)
    6.09 ± 1.36
    6.16 ± 1.411
        Somnolence Score (N = 274, 265)
    29.44 ± 21.618
    28.18 ± 19.884
        Sleep Problem Index (9) Score (N = 274, 265)
    41.11 ± 20.282
    40.64 ± 19.72
        Optimal Sleep Score (N = 273, 265)
    0.34 ± 0.476
    0.38 ± 0.487
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.

    		 Close Top of page
    End point title
    		 Mean change from baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
    End point description
    A self-administered measure consisting of twelve items that assess the key constructs of sleep.Subjects are asked to recall sleep-related activities over the past week. Instrument scoring results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: Number
    least squares mean (confidence interval 95%)
        Sleep Disturbance Score (N = 257, 245)
    -14.71 (-17.57 to -11.85)
    -11.24 (-14.16 to -8.33)
        Sleep Adequancy Score (N=257, 245)
    10.13 (6.49 to 13.76)
    8.16 (4.43 to 11.89)
        Snoring Score (N = 257, 245)
    -2.22 (-5.46 to 1.03)
    -3.27 (-6.59 to 0.04)
        Awaken Short of Breath Score (N = 257, 245)
    -3.61 (-6.3 to -0.92)
    -3.03 (-5.78 to -0.27)
        Quantity of Sleep Score (hours) (N = 257, 245)
    0.42 (0.19 to 0.66)
    0.26 (0.03 to 0.5)
        Somnolence Score (N = 257, 245)
    -1.61 (-3.99 to 0.77)
    -3.74 (-6.17 to -1.31)
        Sleep Problem Index (9) Score (N = 257, 245)
    -9.86 (-12.17 to -7.56)
    -8.19 (-10.55 to -5.83)
        Optimal Sleep Score (N = 256, 245)
    0.11 (0.05 to 0.18)
    0.04 (-0.03 to 0.1)
    Statistical analysis title
    		 Sleep Disturbance Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0545
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8
    Statistical analysis title
    		 Sleep Adequancy Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3913
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.47
         upper limit
    		 2.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.29
    Statistical analysis title
    		 Snoring Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6059
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.06
         upper limit
    		 2.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.04
    Statistical analysis title
    		 Awaken Short of Breath Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7317
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.76
         upper limit
    		 3.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7
    Statistical analysis title
    		 Quantity of Sleep Score (hours)
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2663
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Somnolence Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1562
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.08
         upper limit
    		 0.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Statistical analysis title
    		 Sleep Problem Index (9) Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.249
    Method
    		 ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 4.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.45
    Statistical analysis title
    		 Optimal Sleep Score
    Statistical analysis description
    This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0609
    Method
    		 ANCOVA
    Parameter type
    		 leaet squares mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04

    Secondary: Percentage of participants in MOS-SS with optimal sleep status.

    		 Close Top of page
    End point title
    		 Percentage of participants in MOS-SS with optimal sleep status.
    End point description
    MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: Percentage of participants
    number (not applicable)
        Any Improvements
    21.2
    18.5
        No Change
    66.1
    60.8
        Any Worsening
    6.2
    13.2
        Not applicable
    6.6
    7.5
    Statistical analysis title
    		 Optimal sleep status
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7165 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in thecalculation of p-values.

    Secondary: Percentage of responders to treatment with pregabalin measured as reduction in mean pain score of ≥30%.

    		 Close Top of page
    End point title
    		 Percentage of responders to treatment with pregabalin measured as reduction in mean pain score of ≥30%.
    End point description
    Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: Percentage of participants
    number (not applicable)
        Week 1 (N = 260, 258)
    11.92
    5.04
        Week 2 (N = 254, 244)
    27.17
    20.08
        Week 3 (N = 252, 245)
    38.89
    30.2
        Week 4 (N = 246, 229)
    41.87
    34.5
        Week 5 (N = 241, 226)
    45.64
    38.05
        Week 6 (N = 244, 227)
    48.77
    41.41
        Week 7 (N = 240, 216)
    49.58
    43.06
        Week 8 (N = 236, 213)
    50.42
    46.48
        Week 9 (N = 232, 214)
    50.86
    47.66
        Week 10 (N = 229, 212)
    52.84
    47.17
        Week 11 (N = 231, 211)
    52.38
    51.18
        Week 12 (N = 227, 209)
    54.63
    52.63
        Week 13 (N = 226, 204)
    57.08
    54.41
        Week 14 (N = 223, 208)
    57.4
    54.33
        Week 15 (N = 196, 187)
    57.65
    58.29
    Statistical analysis title
    		 Week 1
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0028
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 6.86
    Statistical analysis title
    		 Week 3
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0235
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.45
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.036
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 2.68
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0619
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 2.24
    Statistical analysis title
    		 Week 5
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0677
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.2
    Statistical analysis title
    		 Week 6
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0707
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.16
    Statistical analysis title
    		 Week 7
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1313
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 2.06
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3072
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.86
    Statistical analysis title
    		 Week 9
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3947
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.8
    Statistical analysis title
    		 Week 11
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6854
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.64
    Statistical analysis title
    		 Week 10
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1462
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 2.05
    Statistical analysis title
    		 Week 12
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5025
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.74
    Statistical analysis title
    		 Week 13
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4908
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.76
    Statistical analysis title
    		 Week 14
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4245
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.8
    Statistical analysis title
    		 Week 15
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8464
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.49

    Secondary: Percentage of responders to treatment with pregabalin measured as reduction in mean pain score of ≥50%

    		 Close Top of page
    End point title
    		 Percentage of responders to treatment with pregabalin measured as reduction in mean pain score of ≥50%
    End point description
    Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    274
    265
    Units: Percentage of participants
    number (not applicable)
        Week 1 (N = 260, 258)
    4.62
    2.33
        Week 2 (N = 254, 244)
    11.42
    6.97
        Week 3 (N = 252, 245)
    22.62
    13.47
        Week 4 (N = 246, 229)
    25.2
    17.9
        Week 5 (N = 241, 226)
    28.22
    19.47
        Week 6 (N = 244, 227)
    29.51
    22.91
        Week 7 (N= 240, 216)
    30.42
    22.22
        Week 8 (N = 236, 213)
    33.05
    27.7
        Week 9 (N = 232, 214)
    34.05
    26.17
        Week 10 (N = 229, 212)
    32.75
    26.42
        Week 11 (N = 231, 211)
    34.2
    25.59
        Week 12 (N = 227, 209)
    37.89
    26.79
        Week 13 (N = 226, 204)
    35.84
    27.45
        Week 14 (N = 223, 208)
    37.67
    29.81
        Week 15 (N = 196, 187)
    39.8
    34.22
    Statistical analysis title
    		 Week 1
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1633
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 6
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0652
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 3.85
    Statistical analysis title
    		 Week 3
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0039
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 3.77
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0382
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 2.83
    Statistical analysis title
    		 Week 5
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0137
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 3.05
    Statistical analysis title
    		 Week 6
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0693
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.49
    Statistical analysis title
    		 Week 7
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0349
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 2.73
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1227
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 2.29
    Statistical analysis title
    		 Week 9
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0364
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 2.63
    Statistical analysis title
    		 Week 10
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0667
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.49
    Statistical analysis title
    		 Week 11
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0176
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 2.84
    Statistical analysis title
    		 Week 12
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.003
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 3.23
    Statistical analysis title
    		 Week 13
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0256
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.74
    Statistical analysis title
    		 Week 14
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0314
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 2.64
    Statistical analysis title
    		 Week 15
    Statistical analysis description
    Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1889
    Method
    		 Gen linear model-logistic link function
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 2.21

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    The active reporting period was from the signing of the informed consent throughout the study including 28 calendar days from the last dose of study medication.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants randomized to receive placebo

    Serious adverse events
    		 Pregabalin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 274 (0.73%)
    7 / 265 (2.64%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Post procedural discharge
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 274 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 274 (0.36%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pregabalin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 274 (27.37%)
    33 / 265 (12.45%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    40 / 274 (14.60%)
    11 / 265 (4.15%)
         occurrences all number
    51
    13
    Somnolence
         subjects affected / exposed
    27 / 274 (9.85%)
    9 / 265 (3.40%)
         occurrences all number
    31
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    14 / 274 (5.11%)
    10 / 265 (3.77%)
         occurrences all number
    16
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    14 / 274 (5.11%)
    8 / 265 (3.02%)
         occurrences all number
    15
    8

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2014
    1.) Change in sample size to a maximum of 700 subjects. Enrollment to continue beyond n=470 until interim analysis results are available. Rationale: to permit enrolling additional subjects if recommended by the study Data Monitoring Committee based on the results of the interim analysis. 2.) Change analysis method for primary efficacy variable to Mixed Model Repeated Measures (MMRM) from Analysis of Covariance (ANCOVA). ANCOVA will become a sensitivity analysis. Rationale: to make more efficient use of weekly mean pain scores. 3.) Change analysis method for sample size re-estimation to be performed by the Data Monitoring Committee at the interim analysis. Rationale: to allow for more efficient use of data in the final analysis. 4.) Change decision rules to be used by the Data Monitoring Committee to make a sample size re-estimation recommendation based on the results of the interim analysis. Rationale: to make more efficient use of data at the interim and final analyses. 5.) Language changed to facilitate subject access to appropriately qualified medical personnel on study related medical questions or problems, to clarify information regarding medication errors, adverse event reporting and communication of study results by Pfizer.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 17:21:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA