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    Clinical Trial Results:
    A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritis

    Summary
    EudraCT number
    2014-003737-26
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    17 Dec 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    04 May 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3191342
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00807846
    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 ClinicalTrials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 8007181021, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of treatment with celecoxib on systolic blood pressure (SBP) compared to treatment with naproxen in subjects with juvenile idiopathic arthritis (JIA) (oligoarticular, polyarticular arthritis and children with systemic onset disease but inactive systemic features).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Sep 2009
    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
    South Africa: 3
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    Ukraine: 27
    Country: Number of subjects enrolled
    United States: 66
    Country: Number of subjects enrolled
    Chile: 8
    Country: Number of subjects enrolled
    Costa Rica: 2
    Country: Number of subjects enrolled
    Peru: 21
    Country: Number of subjects enrolled
    Philippines: 18
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    Serbia: 29
    Worldwide total number of subjects
    198
    EEA total number of subjects
    0
    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)
    96
    Adolescents (12-17 years)
    102
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial in subjects with JIA. A total of 221 subjects were screened into the study in 32 investigator sites.

    Pre-assignment
    Screening details
    A total of 101 subjects were randomized to treatment with Celecoxib and 100 subjects to treatment with Naproxen. Of these randomized, 100 subjects received treatment with Celecoxib and 98 subjects received treatment with Naproxen. Three subjects were randomized but did not receive any treatment.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Celecoxib
    Arm description
    Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Celecoxib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received celecoxib capsules 50 millligram (mg) twice daily (BID) or 100 mg BID for 6 weeks.

    Arm title
    Naproxen
    Arm description
    Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Naproxen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received naproxen suspension 7.5 mg/kilogram (kg) BID (maximum dose of 500 mg BID) for 6 weeks.

    Number of subjects in period 1
    Celecoxib Naproxen
    Started
    100
    98
    Completed
    88
    94
    Not completed
    12
    4
         'Adverse Event '
    5
    -
         'Protocol Violation '
    2
    1
         Lack of efficacy
    2
    -
         'Other Not Specified '
    1
    2
         Consent withdrawn by subject
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Celecoxib
    Reporting group description
    Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit.

    Reporting group title
    Naproxen
    Reporting group description
    Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit.

    Reporting group values
    Celecoxib Naproxen Total
    Number of subjects
    100 98 198
    Age categorical
    Units: Subjects
        Greater than or equal to(>=)2- lessthan (<)8 years
    22 18 40
        >=8 - <13 Years
    34 47 81
        >=13 - <18 Years
    44 33 77
    Gender categorical
    Units: Subjects
        Female
    76 64 140
        Male
    24 34 58

    End points

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    End points reporting groups
    Reporting group title
    Celecoxib
    Reporting group description
    Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit.

    Reporting group title
    Naproxen
    Reporting group description
    Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit.

    Primary: Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit

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    End point title
    Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
    End point description
    Value at 6 weeks minus value at baseline. Safety population included all randomized subjects who received at least one dose of study medication. The safety analysis set was used to analyze all BP (blood pressure) measurements. For early terminations the last observation carried forward (LOCF) was used to impute missing data.
    End point type
    Primary
    End point timeframe
    6 Weeks/Final Visit
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    98
    98
    Units: millimeter of mercury (mmHg)
        least squares mean (standard error)
    0.366 ± 0.7
    -0.734 ± 0.7
    Statistical analysis title
    Change from baseline in SBP at Week 6/Final Visit
    Statistical analysis description
    The primary analysis was based on 90 percentage (%) confidence interval (CI) for the difference across treatment groups (celecoxib – naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.274
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.56
         upper limit
    2.76

    Secondary: Change From Baseline to Week 2 in SBP

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    End point title
    Change From Baseline to Week 2 in SBP
    End point description
    Value at 2 weeks minus value at baseline. Safety population included all randomized subjects who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements. For early terminations the LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    97
    97
    Units: mmHg
        least squares mean (standard error)
    -0.202 ± 0.53
    -1.29 ± 0.53
    Statistical analysis title
    Change from baseline in SBP at Week 2
    Statistical analysis description
    For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.
    Comparison groups
    Naproxen v Celecoxib
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.148 [1]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.088
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.39
         upper limit
    2.57
    Notes
    [1] - Secondary analyses were conducted using a two-sided test with α=0.05.

    Secondary: Change From Baseline in SBP at Week 4

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    End point title
    Change From Baseline in SBP at Week 4
    End point description
    Value at 4 weeks minus value at baseline. Safety population included all randomized subjects who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements. For early terminations the LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    98
    98
    Units: mmHg
        least squares mean (standard error)
    -0.17 ± 0.58
    -2.007 ± 0.58
    Statistical analysis title
    Change from baseline in SBP at Week 4
    Statistical analysis description
    For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.027 [2]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.837
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.21
         upper limit
    3.46
    Notes
    [2] - Secondary analyses were conducted using a two-sided test with α=0.05.

    Secondary: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2

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    End point title
    Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2
    End point description
    Value at 2 weeks minus value at baseline. Safety population included all randomized subjects who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements. For early terminations the LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    97
    97
    Units: mmHg
        least squares mean (standard error)
    -1.346 ± 0.52
    -0.139 ± 0.52
    Statistical analysis title
    Change from baseline in DBP at Week 2
    Statistical analysis description
    For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.106 [3]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.207
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.67
         upper limit
    0.26
    Notes
    [3] - Secondary analyses were conducted using a two-sided test with α=0.05.

    Secondary: Change From Baseline in DBP at Week 4

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    End point title
    Change From Baseline in DBP at Week 4
    End point description
    Value at 4 weeks minus value at baseline. Safety population included all randomized subjects who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements. For early terminations the LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    98
    98
    Units: mmHg
        least squares mean (standard error)
    -0.628 ± 0.54
    -0.848 ± 0.54
    Statistical analysis title
    Change from baseline in DBP at Week 4
    Statistical analysis description
    For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.776 [4]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    1.74
    Notes
    [4] - Secondary analyses were conducted using a two-sided test with α=0.05.

    Secondary: Change From Baseline in DBP at Week 6/Final Visit

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    End point title
    Change From Baseline in DBP at Week 6/Final Visit
    End point description
    Value at 6 weeks/Final Visit minus value at baseline. Safety population included all randomized subjects who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements. For early terminations the LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    98
    98
    Units: mmHg
        least squares mean (standard error)
    -0.535 ± 0.54
    -0.356 ± 0.54
    Statistical analysis title
    Change from baseline in DBP at Week 6
    Statistical analysis description
    For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.815 [5]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.179
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.69
         upper limit
    1.33
    Notes
    [5] - Secondary analyses were conducted using a two-sided test with α=0.05.

    Secondary: Change From Baseline in Parent's Assessment of Overall Well-Being at Week 6/Final Visit

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    End point title
    Change From Baseline in Parent's Assessment of Overall Well-Being at Week 6/Final Visit
    End point description
    The parent/legal guardian evaluated the subject's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor. Modified-Intent-to-Treat (MITT) Population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    96
    98
    Units: millimeter (mm)
        least squares mean (standard error)
    -10.581 ± 2.081
    -13.614 ± 2.06
    Statistical analysis title
    Parent's assessment of overall well-being
    Statistical analysis description
    Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.303 [6]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    3.033
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.76
         upper limit
    8.82
    Notes
    [6] - This analysis was conducted using a two-sided test with α=0.05.

    Secondary: Number of Subjects with >= 30% Improvement in the Parent’s Global Assessment of Overall Well-Being at Week 6/Final Visit

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    End point title
    Number of Subjects with >= 30% Improvement in the Parent’s Global Assessment of Overall Well-Being at Week 6/Final Visit
    End point description
    The parent/legal guardian evaluated the subject's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor. The MITT Population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Week 6/Final Visit
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    96
    98
    Units: Subjects
    47
    54
    Statistical analysis title
    Parent’s global assessment of overall well-being
    Statistical analysis description
    The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed. Mean Difference (Final Values) indicates difference in incidence between treatments.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.392
    Method
    Chi-squared
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.061
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.202
         upper limit
    0.079

    Secondary: Change From Baseline in Subject's Assessment of Overall Well-Being at Week 6/Final Visit

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    End point title
    Change From Baseline in Subject's Assessment of Overall Well-Being at Week 6/Final Visit
    End point description
    Subjects, >= 8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’. MITT population was used. Additional 3 subjects aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 subjects (>=8 yrs) did not provide self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 subject (<8 yrs) provided self-assessment and was included in analysis.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    75
    83
    Units: mm
        least squares mean (standard error)
    -12.99 ± 2.226
    -12.588 ± 2.115
    Statistical analysis title
    Subject's assessment of overall well-being
    Statistical analysis description
    Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.897 [7]
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.402
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.5
         upper limit
    5.69
    Notes
    [7] - This analysis was conducted using a two-sided test with α=0.05.

    Secondary: Number of Subjects with >= 30% Improvement in the Subject's Global Assessment of Overall Well-Being at Week 6/Final Visit

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    End point title
    Number of Subjects with >= 30% Improvement in the Subject's Global Assessment of Overall Well-Being at Week 6/Final Visit
    End point description
    Subjects, >=8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’. MITT population was used. Additional 3 subjects aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 subjects (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 subject (<8 yrs) provided self-assessment and included in analysis.
    End point type
    Secondary
    End point timeframe
    Week 6/Final Visit
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    75
    83
    Units: Subjects
    33
    45
    Statistical analysis title
    Subject's global assessment of overall well-being
    Statistical analysis description
    The number of subjects with at least a 30% improvement in subject's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed. Mean Difference (Final Values) indicates difference in incidence between treatments.
    Comparison groups
    Celecoxib v Naproxen
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2
    Method
    Chi-squared
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.102
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.257
         upper limit
    0.053

    Other pre-specified: Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit

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    End point title
    Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
    End point description
    Ambulatory BP measurements were obtained from 24 subjects (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor. Safety population included all randomized subjects who received at least one dose of study medication. For one subject in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this subject was not included in analysis. ABPM data were analyzed for 12 and 11 subjects in Celecoxib and Naproxen Arms respectively.
    End point type
    Other pre-specified
    End point timeframe
    6 weeks/Final Visit
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    12
    11
    Units: mmHg
    arithmetic mean (standard deviation)
        SBP
    2.4 ± 7.02
    -1.7 ± 12.4
        DBP
    0.9 ± 4.23
    -1.1 ± 5.36
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit

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    End point title
    Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
    End point description
    Ambulatory BP measurements were obtained from 24 subjects (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. Safety population included all randomized subjects who received at least one dose of study medication. For one subject in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this subject was not included in analysis. ABPM data were analyzed for 12 and 11 subjects in Celecoxib and Naproxen Arms respectively.
    End point type
    Other pre-specified
    End point timeframe
    6 weeks/Final Visit
    End point values
    Celecoxib Naproxen
    Number of subjects analysed
    12
    11
    Units: beats per minute (bpm)
        arithmetic mean (standard deviation)
    2.5 ± 6.34
    3.7 ± 8.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 6/Final Visit
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Celecoxib
    Reporting group description
    Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit

    Reporting group title
    Naproxen
    Reporting group description
    Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit

    Serious adverse events
    Celecoxib Naproxen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 98 (1.02%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Celecoxib Naproxen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 100 (10.00%)
    18 / 98 (18.37%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 100 (7.00%)
    4 / 98 (4.08%)
         occurrences all number
    7
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 100 (4.00%)
    9 / 98 (9.18%)
         occurrences all number
    4
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 100 (1.00%)
    5 / 98 (5.10%)
         occurrences all number
    1
    5

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2009
    1. To correct and extend information given on the volume per dose naproxen/placebo in reference to body weight.

    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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