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    Clinical Trial Results:
    A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2010-019872-65
    Trial protocol
    DE   HU   FI   BE   AT   GB   EE   SK   CZ   LT  
    Global end of trial date
    12 Nov 2014

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    MK-0663-108
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01208207
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    12 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate the efficacy and tolerability of two doses of etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with etoricoxib 60 mg. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that the improvement in Spinal Pain Intensity visual analog scare (VAS) as measured by the time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statuses and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. Prior to randomization, participants were allowed to use up to 4 g/day of acetaminophen/paracetamol for severe AS pain. Throughout the treatment period (Part I and II), participants were allowed to use acetaminophen/paracetamol daily as rescue medication for breakthrough pain but were limited to no more than 1.5 g/day. Participants could also take up to 4 g/day of acetaminophen/paracetamol during the 28-day follow-up period.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Belgium: 25
    Country: Number of subjects enrolled
    Romania: 213
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    Slovakia: 39
    Country: Number of subjects enrolled
    South Africa: 59
    Country: Number of subjects enrolled
    Taiwan: 81
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    United States: 40
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Colombia: 17
    Country: Number of subjects enrolled
    Czech Republic: 62
    Country: Number of subjects enrolled
    Estonia: 18
    Country: Number of subjects enrolled
    Finland: 10
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 63
    Country: Number of subjects enrolled
    Hungary: 178
    Country: Number of subjects enrolled
    India: 35
    Country: Number of subjects enrolled
    Lithuania: 15
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Poland: 68
    Worldwide total number of subjects
    1015
    EEA total number of subjects
    707
    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)
    961
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1149 participants were screened for inclusion in the study and 1015 of these participants were randomized.

    Period 1
    Period 1 title
    Part I
    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
    Etoricoxib 60 mg (Part I)
    Arm description
    One etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.
    Arm type
    Experimental

    Investigational medicinal product name
    Etoricoxib 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib 60 mg oral tablet once daily

    Investigational medicinal product name
    Naproxen-matching placebo 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen-matching placebo 500 mg oral tablet twice daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 90 mg oral tablet once daily

    Arm title
    Etoricoxib 90 mg (Part I)
    Arm description
    One etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.
    Arm type
    Experimental

    Investigational medicinal product name
    Etoricoxib 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib 90 mg oral tablet once daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 60 mg oral tablet once daily

    Investigational medicinal product name
    Naproxen-matching placebo 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen-matching placebo 500 mg oral tablet twice daily

    Arm title
    Naproxen 1000 mg (Part I)
    Arm description
    One naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I.
    Arm type
    Active comparator

    Investigational medicinal product name
    Etoricoxib-matching placebo 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 60 mg oral tablet once daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 90 mg oral tablet once daily

    Investigational medicinal product name
    Naproxen 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen 500 mg oral tablet twice daily

    Number of subjects in period 1
    Etoricoxib 60 mg (Part I) Etoricoxib 90 mg (Part I) Naproxen 1000 mg (Part I)
    Started
    702
    156
    157
    Completed
    632
    145
    142
    Not completed
    70
    11
    15
         Protocol deviation
    8
    -
    2
         Physician decision
    -
    1
    -
         Lack of efficacy
    21
    3
    2
         Non-Compliance With Study Drug
    1
    -
    1
         Adverse event, non-fatal
    19
    2
    6
         Progressive Disease
    1
    -
    -
         Consent withdrawn by subject
    14
    4
    4
         Lost to follow-up
    6
    1
    -
    Period 2
    Period 2 title
    Part II
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Etoricoxib 60 mg / Etoricoxib 60 mg (Part II)
    Arm description
    Participants who received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.
    Arm type
    Experimental

    Investigational medicinal product name
    Etoricoxib 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib 60 mg oral tablet once daily

    Investigational medicinal product name
    Naproxen-matching placebo 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen-matching placebo 500 mg oral tablet twice daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 90 mg oral tablet once daily

    Arm title
    Etoricoxib 60 mg / Etoricoxib 90 mg (Part II)
    Arm description
    Participants who received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.
    Arm type
    Experimental

    Investigational medicinal product name
    Etoricoxib 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib 90 mg oral tablet once daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 60 mg oral tablet once daily

    Investigational medicinal product name
    Naproxen-matching placebo 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen-matching placebo 500 mg oral tablet twice daily

    Arm title
    Etoricoxib 90 mg / Etoricoxib 90 mg (Part II)
    Arm description
    Participants who received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.
    Arm type
    Experimental

    Investigational medicinal product name
    Etoricoxib 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib 90 mg oral tablet once daily

    Investigational medicinal product name
    Naproxen-matching placebo 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen-matching placebo 500 mg oral tablet twice daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 60 mg oral tablet once daily

    Arm title
    Naproxen 1000 mg /Naproxen 1000 mg (Part II)
    Arm description
    Participants who received one naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I received one naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 20 weeks in Part II.
    Arm type
    Active comparator

    Investigational medicinal product name
    Naproxen 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen 500 mg oral tablet twice daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 90 mg oral tablet once daily

    Investigational medicinal product name
    Etoricoxib-matching placebo 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Etoricoxib-matching placebo 60 mg oral tablet once daily

    Number of subjects in period 2
    Etoricoxib 60 mg / Etoricoxib 60 mg (Part II) Etoricoxib 60 mg / Etoricoxib 90 mg (Part II) Etoricoxib 90 mg / Etoricoxib 90 mg (Part II) Naproxen 1000 mg /Naproxen 1000 mg (Part II)
    Started
    314
    318
    145
    142
    Completed
    282
    295
    129
    131
    Not completed
    32
    23
    16
    11
         Protocol deviation
    1
    -
    -
    -
         Physician decision
    1
    -
    2
    -
         Lack of efficacy
    6
    4
    3
    3
         Non-Compliance With Study Drug
    4
    1
    1
    -
         Adverse event, non-fatal
    5
    9
    4
    2
         Consent withdrawn by subject
    10
    9
    3
    5
         Technical Problems
    1
    -
    1
    -
         Lost to follow-up
    4
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etoricoxib 60 mg (Part I)
    Reporting group description
    One etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.

    Reporting group title
    Etoricoxib 90 mg (Part I)
    Reporting group description
    One etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.

    Reporting group title
    Naproxen 1000 mg (Part I)
    Reporting group description
    One naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I.

    Reporting group values
    Etoricoxib 60 mg (Part I) Etoricoxib 90 mg (Part I) Naproxen 1000 mg (Part I) Total
    Number of subjects
    702 156 157 1015
    Age categorical
    Units: Subjects
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    45.4 ± 12.4 45.2 ± 11.3 44.5 ± 12.3 -
    Gender, Male/Female
    Units: Participants
        Female
    209 45 41 295
        Male
    493 111 116 720
    Study Specific Characteristic |
    Units: mm VAS
        arithmetic mean (standard deviation)
    76.7 ± 14.2 76.7 ± 15.2 77 ± 14 -

    End points

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    End points reporting groups
    Reporting group title
    Etoricoxib 60 mg (Part I)
    Reporting group description
    One etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.

    Reporting group title
    Etoricoxib 90 mg (Part I)
    Reporting group description
    One etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.

    Reporting group title
    Naproxen 1000 mg (Part I)
    Reporting group description
    One naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I.
    Reporting group title
    Etoricoxib 60 mg / Etoricoxib 60 mg (Part II)
    Reporting group description
    Participants who received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.

    Reporting group title
    Etoricoxib 60 mg / Etoricoxib 90 mg (Part II)
    Reporting group description
    Participants who received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.

    Reporting group title
    Etoricoxib 90 mg / Etoricoxib 90 mg (Part II)
    Reporting group description
    Participants who received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.

    Reporting group title
    Naproxen 1000 mg /Naproxen 1000 mg (Part II)
    Reporting group description
    Participants who received one naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I received one naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 20 weeks in Part II.

    Subject analysis set title
    Etoricoxib 60 mg (Part I)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    One etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.

    Subject analysis set title
    Etoricoxib 90 mg (Part I)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    One etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I.

    Subject analysis set title
    Naproxen 1000 mg (Part I)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    One naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I.

    Subject analysis set title
    Etoricoxib 60 mg / Etoricoxib 60 mg (Part II)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.

    Subject analysis set title
    Etoricoxib 60 mg / Etoricoxib 90 mg (Part II)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received one etoricoxib 60 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.

    Subject analysis set title
    Etoricoxib 90 mg / Etoricoxib 90 mg (Part II)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 6 weeks in Part I received one etoricoxib 90 mg tablet, one 60 mg etoricoxib-matching placebo tablet, and one 500 mg naproxen-matching placebo tablet taken orally in the morning, and one 500 mg naproxen-matching placebo tablet taken orally in the evening for 20 weeks in Part II.

    Subject analysis set title
    Naproxen 1000 mg /Naproxen 1000 mg (Part II)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received one naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 6 weeks in Part I received one naproxen 500 mg tablet, one 90 mg etoricoxib-matching placebo tablet, and one 60 mg etoricoxib-matching placebo tablet taken orally in the morning, and one naproxen 500 mg tablet taken orally in the evening for 20 weeks in Part II.

    Primary: Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 90 mg vs. naproxen

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    End point title
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 90 mg vs. naproxen [1]
    End point description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. Participants were from the Per-Protocol Population which excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and up to Week 6
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical comparisons between other arms were neither planned nor performed for this primary endpoint.
    End point values
    Etoricoxib 90 mg (Part I) Naproxen 1000 mg (Part I)
    Number of subjects analysed
    144
    143
    Units: mm VAS
        least squares mean (confidence interval 95%)
    -31.23 (-34.7 to -27.76)
    -30.59 (-34.07 to -27.1)
    Statistical analysis title
    Etoricoxib 90 mg v Naproxen 1000 mg
    Comparison groups
    Etoricoxib 90 mg (Part I) v Naproxen 1000 mg (Part I)
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    ANCOVA
    Parameter type
    Difference in Least Squares Mean
    Point estimate
    -0.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.47
         upper limit
    4.19
    Notes
    [2] - The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).

    Primary: Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 60 mg vs. naproxen

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    End point title
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 60 mg vs. naproxen [3]
    End point description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. Participants were from the Per-Protocol Population which excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and up to Week 6
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical comparisons between other arms were neither planned nor performed for this primary endpoint.
    End point values
    Etoricoxib 60 mg (Part I) Naproxen 1000 mg (Part I)
    Number of subjects analysed
    660
    143
    Units: mm VAS
        least squares mean (confidence interval 95%)
    -29 (-30.69 to -27.31)
    -30.59 (-34.07 to -27.1)
    Statistical analysis title
    Etoricoxib 60 mg v Naproxen 1000 mg
    Comparison groups
    Etoricoxib 60 mg (Part I) v Naproxen 1000 mg (Part I)
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    ANCOVA
    Parameter type
    Difference in Least Squares Mean
    Point estimate
    1.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.19
         upper limit
    5.37
    Notes
    [4] - The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).

    Primary: Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)

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    End point title
    Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) [5]
    End point description
    Participants were from the All Participants as Treated (APaT) Population which included the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60 mg / Etoricoxib 90 mg (Part II) arm.
    End point type
    Primary
    End point timeframe
    Up to 26 weeks
    Notes
    [5] - 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 analysis was planned for this primary endpoint.
    End point values
    Etoricoxib 60 mg (Part I) Etoricoxib 90 mg (Part I) Naproxen 1000 mg (Part I) Etoricoxib 60 mg / Etoricoxib 60 mg (Part II) Etoricoxib 60 mg / Etoricoxib 90 mg (Part II) Etoricoxib 90 mg / Etoricoxib 90 mg (Part II) Naproxen 1000 mg /Naproxen 1000 mg (Part II)
    Number of subjects analysed
    702
    155
    156
    313
    319
    145
    142
    Units: Participants
    22
    2
    6
    3
    9
    4
    2
    No statistical analyses for this end point

    Secondary: Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 90 mg vs. etoricoxib 60 mg

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    End point title
    Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: etoricoxib 90 mg vs. etoricoxib 60 mg [6]
    End point description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. Participants were from the Modified Intent-to-Treat (mITT) Population in Part I which consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 6
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical comparisons between other arms were neither planned nor performed for this primary endpoint.
    End point values
    Etoricoxib 60 mg (Part I) Etoricoxib 90 mg (Part I)
    Number of subjects analysed
    694
    153
    Units: mm VAS
        least squares mean (confidence interval 95%)
    -28.94 (-30.58 to -27.29)
    -30.51 (-33.87 to -27.15)
    Statistical analysis title
    Etoricoxib 60 mg v Etoricoxib 90 mg
    Comparison groups
    Etoricoxib 60 mg (Part I) v Etoricoxib 90 mg (Part I)
    Number of subjects included in analysis
    847
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.396
    Method
    ANCOVA
    Parameter type
    Difference in Least Squares Mean
    Point estimate
    -1.58
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -3.96
         upper limit
    0.81

    Secondary: Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: etoricoxib 60/90 mg vs. etoricoxib 60 mg (non-responders from Part I)

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    End point title
    Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: etoricoxib 60/90 mg vs. etoricoxib 60 mg (non-responders from Part I)
    End point description
    Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change was calculated as the average VAS value over Weeks 10 and 12 minus the VAS at Week 6. Participants were from the Modified Intent-to-Treat (mITT) Population in Part I which consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.
    End point type
    Secondary
    End point timeframe
    Week 6 to Week 10 and Week 12
    End point values
    Etoricoxib 60 mg / Etoricoxib 60 mg (Part II) Etoricoxib 60 mg / Etoricoxib 90 mg (Part II)
    Number of subjects analysed
    175
    178
    Units: mm VAS
        least squares mean (confidence interval 95%)
    -7.26 (-9.73 to -4.8)
    -9.97 (-12.42 to -7.51)
    Statistical analysis title
    Etoricoxib 60 mg/60 mg v 60 mg/90 mg
    Comparison groups
    Etoricoxib 60 mg / Etoricoxib 60 mg (Part II) v Etoricoxib 60 mg / Etoricoxib 90 mg (Part II)
    Number of subjects included in analysis
    353
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.112
    Method
    ANCOVA
    Parameter type
    Difference in Least Squares Mean
    Point estimate
    -2.7
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -4.88
         upper limit
    -0.52

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 30 (including up to 28 days after last dose of study drug)
    Adverse event reporting additional description
    AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Etoricoxib 90 mg / Etoricoxib 90 mg
    Reporting group description
    Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.

    Reporting group title
    Etoricoxib 60 mg / Etoricoxib 90 mg
    Reporting group description
    Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.

    Reporting group title
    Etoricoxib 60 mg / Etoricoxib 60 mg
    Reporting group description
    Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.

    Reporting group title
    Etoricoxib 90 mg
    Reporting group description
    Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.

    Reporting group title
    Etoricoxib 60 mg
    Reporting group description
    Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.

    Reporting group title
    Naproxen 1000 mg
    Reporting group description
    Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.

    Reporting group title
    Naproxen 1000 mg / Naproxen 1000 mg
    Reporting group description
    Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.

    Serious adverse events
    Etoricoxib 90 mg / Etoricoxib 90 mg Etoricoxib 60 mg / Etoricoxib 90 mg Etoricoxib 60 mg / Etoricoxib 60 mg Etoricoxib 90 mg Etoricoxib 60 mg Naproxen 1000 mg Naproxen 1000 mg / Naproxen 1000 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 145 (4.14%)
    7 / 319 (2.19%)
    1 / 313 (0.32%)
    0 / 10 (0.00%)
    5 / 70 (7.14%)
    0 / 14 (0.00%)
    2 / 142 (1.41%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ear neoplasm
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin abrasion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular hypertrophy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 145 (1.38%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    1 / 313 (0.32%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sialoadenitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Etoricoxib 90 mg / Etoricoxib 90 mg Etoricoxib 60 mg / Etoricoxib 90 mg Etoricoxib 60 mg / Etoricoxib 60 mg Etoricoxib 90 mg Etoricoxib 60 mg Naproxen 1000 mg Naproxen 1000 mg / Naproxen 1000 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 145 (16.55%)
    50 / 319 (15.67%)
    55 / 313 (17.57%)
    6 / 10 (60.00%)
    18 / 70 (25.71%)
    9 / 14 (64.29%)
    25 / 142 (17.61%)
    Vascular disorders
    Hypertension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 145 (5.52%)
    15 / 319 (4.70%)
    18 / 313 (5.75%)
    0 / 10 (0.00%)
    4 / 70 (5.71%)
    2 / 14 (14.29%)
    8 / 142 (5.63%)
         occurrences all number
    8
    16
    21
    0
    4
    2
    8
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 145 (0.00%)
    7 / 319 (2.19%)
    9 / 313 (2.88%)
    1 / 10 (10.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    0
    7
    10
    1
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    2 / 313 (0.64%)
    1 / 10 (10.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 145 (0.69%)
    6 / 319 (1.88%)
    1 / 313 (0.32%)
    1 / 10 (10.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    6
    1
    1
    0
    0
    0
    Dry throat
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Throat tightness
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    2 / 313 (0.64%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    9 / 145 (6.21%)
    13 / 319 (4.08%)
    10 / 313 (3.19%)
    1 / 10 (10.00%)
    4 / 70 (5.71%)
    1 / 14 (7.14%)
    5 / 142 (3.52%)
         occurrences all number
    11
    18
    15
    1
    13
    1
    5
    Anosmia
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 145 (0.00%)
    4 / 319 (1.25%)
    1 / 313 (0.32%)
    0 / 10 (0.00%)
    2 / 70 (2.86%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    10
    1
    0
    2
    1
    0
    Dysgeusia
         subjects affected / exposed
    3 / 145 (2.07%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    1 / 10 (10.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    1
    0
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 145 (1.38%)
    8 / 319 (2.51%)
    15 / 313 (4.79%)
    0 / 10 (0.00%)
    3 / 70 (4.29%)
    0 / 14 (0.00%)
    10 / 142 (7.04%)
         occurrences all number
    2
    12
    28
    0
    6
    0
    10
    Abdominal discomfort
         subjects affected / exposed
    0 / 145 (0.00%)
    7 / 319 (2.19%)
    4 / 313 (1.28%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    1 / 142 (0.70%)
         occurrences all number
    0
    8
    4
    0
    0
    1
    2
    Abdominal pain
         subjects affected / exposed
    0 / 145 (0.00%)
    3 / 319 (0.94%)
    3 / 313 (0.96%)
    1 / 10 (10.00%)
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    3
    3
    1
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 145 (1.38%)
    8 / 319 (2.51%)
    7 / 313 (2.24%)
    1 / 10 (10.00%)
    4 / 70 (5.71%)
    1 / 14 (7.14%)
    4 / 142 (2.82%)
         occurrences all number
    2
    8
    7
    1
    6
    1
    5
    Nausea
         subjects affected / exposed
    3 / 145 (2.07%)
    3 / 319 (0.94%)
    5 / 313 (1.60%)
    0 / 10 (0.00%)
    4 / 70 (5.71%)
    2 / 14 (14.29%)
    1 / 142 (0.70%)
         occurrences all number
    3
    4
    5
    0
    4
    2
    1
    Retching
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 319 (0.00%)
    0 / 313 (0.00%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 145 (0.00%)
    2 / 319 (0.63%)
    2 / 313 (0.64%)
    0 / 10 (0.00%)
    1 / 70 (1.43%)
    1 / 14 (7.14%)
    0 / 142 (0.00%)
         occurrences all number
    0
    2
    2
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 145 (0.69%)
    1 / 319 (0.31%)
    2 / 313 (0.64%)
    1 / 10 (10.00%)
    2 / 70 (2.86%)
    0 / 14 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    1
    1
    2
    1
    2
    0
    2
    Rash
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 319 (0.31%)
    4 / 313 (1.28%)
    1 / 10 (10.00%)
    2 / 70 (2.86%)
    0 / 14 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    5
    1
    2
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 145 (0.69%)
    1 / 319 (0.31%)
    1 / 313 (0.32%)
    1 / 10 (10.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 145 (4.83%)
    21 / 319 (6.58%)
    17 / 313 (5.43%)
    0 / 10 (0.00%)
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    4 / 142 (2.82%)
         occurrences all number
    7
    21
    19
    0
    0
    0
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2013
    The exclusion criteria was updated to exclude participants with an active duodenal ulcer or with any degree of hepatic insufficiency.
    13 Nov 2013
    The sample size was reduced from 1300 participants to approximately 900 participants.

    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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