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    Clinical Trial Results:
    Double-blind, randomised, placebo and active controlled, parallel group study to evaluate the analgesic effect of a single oral administration of four different combination doses of DKP.TRIS with TRAM.HCl in comparison with the single agents, on moderate to severe pain following impacted third mandibular molar tooth extraction

    Summary
    EudraCT number
    		 2010-022798-32
    Trial protocol
    		 GB   DE   ES   HU   IT   PL  
    Global end of trial date
    14 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2018
    First version publication date
    03 Nov 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DEX-TRA 02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01307020
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A
    Sponsor organisation address
    Via Sette Santi, 1, Flrorence, Italy, 50131
    Public contact
    Corporate Director, Clinical Sciences, Menarini Ricerche, S.p.A, Menarini Ricerche, S.p.A, 39 05556809990, acapriati@menarini-ricerche.it
    Scientific contact
    Corporate Director, Clinical Sciences, Menarini Ricerche, S.p.A, Menarini Ricerche, S.p.A, 39 05556809990, acapriati@menarini-ricerche.it
    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
    15 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the analgesic efficacy of DKP.TRIS and TRAM.HCl given as fixed combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.
    Protection of trial subjects
    If any event(s) related to the conduct of the study or the development of the IMP affected the safety of the study participants, the Sponsor and the investigator would have taken appropriate urgent safety measures to protect the subjects against any immediate hazard. The CA and IRB/EC would have been informed forthwith about these new events and the measures taken. For subjects participating in the study, Menarini Ricerche S.p.A. stipulated an insurance policy in accordance with local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Feb 2011
    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
    Poland: 51
    Country: Number of subjects enrolled
    Spain: 141
    Country: Number of subjects enrolled
    United Kingdom: 180
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 129
    Country: Number of subjects enrolled
    Italy: 94
    Worldwide total number of subjects
    611
    EEA total number of subjects
    611
    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)
    611
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 First patient in (screening) 23 Feb 2011, last patient out 14 Oct 2011. At 16 study centres in 6 European countries (Germany, Italy, Hungary, Poland, Spain and United Kingdom).

    Pre-assignment
    Screening details
    		 The trial encompassed 3 visits: 1-Screening; 2-Dental surgery (patients who have moderate to severe pain afterwards were randomised and received study drug); 3-End of study. Overall, 745 patients were enrolled (screened), of them 611 were randomized to receive the study drug and therefore considered as started.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo, oral film-coated table, once
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral film-coated tablet, once

    Arm title
    		 Ibuprofen
    Arm description
    		 Ibuprofen 400 mg, oral film-coated table, once
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ibuprofen 400 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen 400 mg, oral film-coated table, once

    Arm title
    		 TRAM.HCl 75mg
    Arm description
    		 Tramadol Hydrochloride high dose, oral film-coated table, once
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TRAM.HCl 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TRAM.HCl 75mg, oral film-coated table, once

    Arm title
    		 TRAM.HCl 37.5mg
    Arm description
    		 Tramadol Hydrochloride low dose, oral film-coated table, once
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TRAM.HCl 37.5mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TRAM.HCl 37.5mg, oral film-coated tablet, once

    Arm title
    		 DKP-TRIS 25mg
    Arm description
    		 Dexketoprofen Trometamol high dose, oral film-coated table, once
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DKP-TRIS 25mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DKP-TRIS 25mg, oral film-coated tablet, once

    Arm title
    		 DKP-TRIS 12.5mg
    Arm description
    		 Dexketoprofen Trometamol low dose, oral film-coated table, once
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DKP-TRIS 12.5mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DKP-TRIS 12.5mg, oral film-coated tablet, once

    Arm title
    		 DKP-TRIS 25mg - TRAM.HCl 75mg
    Arm description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride high dose, oral film-coated table, once
    Arm type
    		 Experimental

    Investigational medicinal product name
    DKP-TRIS 25mg - TRAM.HCl 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DKP-TRIS 25mg - TRAM.HCl 75mg,oral film-coated tablet, once

    Arm title
    		 DKP-TRIS 25mg - TRAM.HCl 37.5mg
    Arm description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride low dose, oral film-coated table, once
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexketoprofen Trometamol high dose + Tramadol Hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexketoprofen Trometamol high dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Arm title
    		 DKP-TRIS 12.5mg - TRAM.HCl 75mg
    Arm description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride high dose, oral film-coated table, once
    Arm type
    		 Experimental

    Investigational medicinal product name
    DKP-TRIS 12.5mg - TRAM.HCl 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once

    Arm title
    		 DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Arm description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride low dose, oral film-coated table, once
    Arm type
    		 Experimental

    Investigational medicinal product name
    DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DKP-TRIS 12.5mg - TRAM.HCl 37.5mg, oral Film-coated tablet, once

    Number of subjects in period 1
    		Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 12.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Started
    62
    61
    60
    59
    61
    60
    61
    63
    63
    61
    Completed
    62
    61
    60
    58
    61
    60
    60
    62
    62
    61
    Not completed
    0
    0
    0
    1
    0
    0
    1
    1
    1
    0
         Failure of eDiary
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    -
    1
    -
    -
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, oral film-coated table, once

    Reporting group title
    Ibuprofen
    Reporting group description
    		 Ibuprofen 400 mg, oral film-coated table, once

    Reporting group title
    TRAM.HCl 75mg
    Reporting group description
    		 Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    TRAM.HCl 37.5mg
    Reporting group description
    		 Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg - TRAM.HCl 75mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg - TRAM.HCl 37.5mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg - TRAM.HCl 75mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group values
    		 Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 12.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg Total
    Number of subjects
    		 62 61 60 59 61 60 61 63 63 61 611
    Age categorical
    Units: Subjects
        In utero
    		 0
        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)
    		 26.1 ( 6.64 ) 26.6 ( 6.48 ) 27.8 ( 7.99 ) 25.5 ( 7.15 ) 26.9 ( 6.94 ) 27.0 ( 9.85 ) 27.3 ( 7.55 ) 26.3 ( 7.33 ) 26.9 ( 7.62 ) 28.6 ( 7.64 ) -
    Gender categorical
    Units: Subjects
        Female
    		 33 41 28 38 44 36 34 36 39 35 364
        Male
    		 29 20 32 21 17 24 27 27 24 26 247
    BMI
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    		 22.7 ( 2.80 ) 22.4 ( 3.04 ) 24.2 ( 3.08 ) 23.0 ( 3.19 ) 23.5 ( 3.30 ) 23.6 ( 3.20 ) 23.2 ( 3.19 ) 23.0 ( 2.87 ) 24.1 ( 3.69 ) 23.7 ( 3.39 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, oral film-coated table, once

    Reporting group title
    Ibuprofen
    Reporting group description
    		 Ibuprofen 400 mg, oral film-coated table, once

    Reporting group title
    TRAM.HCl 75mg
    Reporting group description
    		 Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    TRAM.HCl 37.5mg
    Reporting group description
    		 Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg - TRAM.HCl 75mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg - TRAM.HCl 37.5mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg - TRAM.HCl 75mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Primary: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing

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    End point title
    		 Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing
    End point description
    Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %
    End point type
    Primary
    End point timeframe
    6 hours
    End point values
    		 Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 12.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Number of subjects analysed
    62
    60
    59
    59
    60
    60
    61
    63
    62
    60
    Units: percent of patients
        number (not applicable)
    9.7
    45.0
    25.4
    10.2
    55.0
    26.7
    72.1
    55.6
    59.7
    36.7
    Statistical analysis title
    		 % of responders (at least 50% max TOTPAR) over 6 h
    Comparison groups
    Placebo v Ibuprofen v TRAM.HCl 75mg v TRAM.HCl 37.5mg v DKP-TRIS 25mg v DKP-TRIS 12.5mg v DKP-TRIS 25mg - TRAM.HCl 75mg v DKP-TRIS 25mg - TRAM.HCl 37.5mg v DKP-TRIS 12.5mg - TRAM.HCl 75mg v DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.

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    End point title
    		 Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.
    End point description
    Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %
    End point type
    Secondary
    End point timeframe
    4, 8 and 12 hours
    End point values
    		 Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 12.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Number of subjects analysed
    62
    60
    59
    59
    60
    60
    61
    63
    62
    60
    Units: percent of patients
    number (not applicable)
        at 4 hours post-dose
    6.5
    56.7
    23.7
    11.9
    65.0
    40.0
    78.7
    65.1
    72.6
    63.3
        at 8 hours post- dose
    6.5
    33.3
    20.3
    6.8
    31.7
    16.7
    54.1
    44.4
    48.4
    21.7
        at 12 hours post- dose
    6.5
    25.0
    15.3
    5.1
    13.3
    10.0
    37.7
    28.6
    35.5
    11.7
    No statistical analyses for this end point

    Secondary: Percentage of Patients Using Rescue Medication at 6 Hours

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    End point title
    		 Percentage of Patients Using Rescue Medication at 6 Hours
    End point description
    Percentage of patients using rescue medication at 6 hours post-dosing.
    End point type
    Secondary
    End point timeframe
    Baseline to 6 hours
    End point values
    		 Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 12.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Number of subjects analysed
    62
    60
    59
    59
    60
    60
    61
    63
    62
    60
    Units: percentage of patients
        number (not applicable)
    72.6
    48.3
    64.4
    69.5
    53.3
    65.0
    37.7
    39.7
    46.8
    66.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    10 ± 3 days
    Adverse event reporting additional description
    Analyzed for the Safety population (all patients who received study treatment)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, oral film- coated table, once

    Reporting group title
    Ibuprofen
    Reporting group description
    		 Ibuprofen 400 mg, oral film-coated table, once

    Reporting group title
    TRAM.HCl 75mg
    Reporting group description
    		 Tramadol Hydrochloride high dose,oral film-coated table, once

    Reporting group title
    TRAM.HCl 37.5mg
    Reporting group description
    		 Tramadol Hydrochloride low dose,oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg - TRAM.HCl 75mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 25mg - TRAM.HCl 37.5mg
    Reporting group description
    		 Dexketoprofen Trometamol high dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg - TRAM.HCl 75mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride high dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
    Reporting group description
    		 Dexketoprofen Trometamol low dose + Tramadol Hydrochloride low dose, oral film-coated table, once

    Reporting group title
    DKP-TRIS 12.5mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Ibuprofen TRAM.HCl 75mg TRAM.HCl 37.5mg DKP-TRIS 25mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 62 (1.61%)
    5 / 61 (8.20%)
    14 / 60 (23.33%)
    5 / 59 (8.47%)
    4 / 61 (6.56%)
    10 / 61 (16.39%)
    6 / 63 (9.52%)
    9 / 63 (14.29%)
    7 / 61 (11.48%)
    2 / 60 (3.33%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 61 (3.28%)
    4 / 60 (6.67%)
    2 / 59 (3.39%)
    0 / 61 (0.00%)
    3 / 61 (4.92%)
    1 / 63 (1.59%)
    5 / 63 (7.94%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    4
    2
    0
    3
    1
    5
    1
    0
    Headache
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 61 (1.64%)
    2 / 60 (3.33%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    2 / 63 (3.17%)
    1 / 63 (1.59%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    2
    3
    0
    0
    2
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 61 (1.64%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    2 / 61 (3.28%)
    3 / 61 (4.92%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    3 / 61 (4.92%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    3
    1
    2
    3
    0
    0
    3
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 61 (0.00%)
    6 / 60 (10.00%)
    1 / 59 (1.69%)
    1 / 61 (1.64%)
    4 / 61 (6.56%)
    1 / 63 (1.59%)
    4 / 63 (6.35%)
    4 / 61 (6.56%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    7
    1
    1
    4
    2
    4
    4
    2
    Vomiting
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 61 (3.28%)
    5 / 60 (8.33%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
    5 / 61 (8.20%)
    3 / 63 (4.76%)
    4 / 63 (6.35%)
    3 / 61 (4.92%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    5
    0
    2
    6
    3
    4
    4
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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