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    Clinical Trial Results:
    Analgesic efficacy of oral dexketoprofen trometamol/tramadol hydrochloride versus tramadol hydrochloride/paracetamol: a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.

    Summary
    EudraCT number
    		 2015-004152-22
    Trial protocol
    		 GB   HU   ES   PL   IT  
    Global end of trial date
    14 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2018
    First version publication date
    27 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEX-TRA-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02777970
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A.
    Sponsor organisation address
    Via Sette Santi 1, Florence, Italy, 50131
    Public contact
    Cl. Sciences Corporate Director, Menarini Ricerche S.p.A., +39 0555680 9990, ACapriati@menarini-ricerche.it
    Scientific contact
    Cl. Sciences Corporate Director, Menarini Ricerche S.p.A., +39 0555680 9990, 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
    04 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the comparability of DKP.TRIS/TRAM.HCl and TRAM.HCl/paracetamol in terms of analgesic efficacy on moderate to severe pain following impacted lower third molar extraction.
    Protection of trial subjects
    Rescue medication, namely Ibuprofen 400 mg, was available at any time during the post-dose period.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2016
    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
    Italy: 180
    Country: Number of subjects enrolled
    Poland: 127
    Country: Number of subjects enrolled
    Spain: 141
    Country: Number of subjects enrolled
    United Kingdom: 139
    Country: Number of subjects enrolled
    Hungary: 67
    Worldwide total number of subjects
    654
    EEA total number of subjects
    654
    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)
    1
    Adults (18-64 years)
    653
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 18 sites across 5 European countries: Hungary, Italy, Poland, Spain and United Kingdom. The clinical phase of the study started on 28th April 2016 (first enrolled patient, randomised on 11h May) and concluded on 14th February 2017 (last patient out). 1 patient was excluded from all the analyses because <18 years old

    Pre-assignment
    Screening details
    		 Male or female patients, age> 18 years, experiencing moderate to severe pain (Numerical Rating Scale, NRS ≥4) within 4 hours after the end of surgery (under local anaesthesia) for extraction of at least one impacted lower third molar. Screened 792, randomised 654. Main SF reason: pain<4 (49), incl/excl crit (31), other (45), withdrawal(13).

    Period 1
    Period 1 title
    Screening period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Screening
    Arm description
    		 Screening period for study eligibility assessment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Screening
    Started
    653
    Completed
    653
    Period 2
    Period 2 title
    Treatment/assessment period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Double dummy technique used for this study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DKP.TRIS/TRAM.HCl
    Arm description
    		 Dexketoprofen trometamol/Tramadol hydrochloride 25mg /75mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexketoprofen trometamol/Tramadol hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of dexketoprofen trometamol/Tramadol hydrochloride 25mg /75mg fixed dose combination oral tablet plus 2 tablets of placebo matching the active comparator

    Arm title
    		 TRAM.HCl/ Paracetamol
    Arm description
    		 Tramadol hydrochloride/ Paracetamol 75mg/650mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tramadol / Paracetamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of tramadol hydrochloride / paracetamol 75mg/650mg as 2 x [37.5 mg/325 mg] fixed dose combination oral tablets plus 1 tablet of placebo matching DKP.TRIS/TRAM.HCl

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching DKP.TRIS/TRAM.HCl and TRAM.HCl/Paracetamol
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of 1 tablet placebo matching DKP.TRIS/TRAM.HCl 25/75 mg plus 2 tablets placebo matching TRAM.HCl/Paracetamol 37.5/325 mg

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: period 2 is the baseline period since the pain intensity assessed at T0, after the randomization, immediately prior to the administration of the study treatment, was considered as baseline pain intensity.
    Number of subjects in period 2 [2]
    		DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo
    Started
    260
    262
    131
    Completed
    260
    262
    131
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: one patient was excluded from all the analyses because underage

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DKP.TRIS/TRAM.HCl
    Reporting group description
    		 Dexketoprofen trometamol/Tramadol hydrochloride 25mg /75mg

    Reporting group title
    TRAM.HCl/ Paracetamol
    Reporting group description
    		 Tramadol hydrochloride/ Paracetamol 75mg/650mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching DKP.TRIS/TRAM.HCl and TRAM.HCl/Paracetamol

    Reporting group values
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo Total
    Number of subjects
    		 260 262 131 653
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 260 262 131 653
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Mean Age at the Informed Consent signature date
    Units: years
        arithmetic mean (standard deviation)
    		 26.8 ( 7.48 ) 27.1 ( 8.13 ) 26.5 ( 7.67 ) -
    Gender categorical
    Male and females patients could be enrolled, no rule adopted.
    Units: Subjects
        Female
    		 152 158 78 388
        Male
    		 108 104 53 265
    Pain Intensity at Qualification
    Descriptive Statistics of Pain Intensity scores at Qualification (namely within 4 hours after the end of the surgery) measured on a Numerical Rating Scale (NRS) from 0 to 10
    Units: point
        arithmetic mean (standard deviation)
    		 5 ( 1.19 ) 4.9 ( 1.12 ) 4.8 ( 1.1 ) -
    Pain Intensity at T-0h (baseline)
    Descriptive statistics of Pain Intensity at T-oh (baseline defined as NRS-PI assessed immediately prior to drug administration) measured on a NRS from 0 to 10
    Units: point
        arithmetic mean (standard deviation)
    		 5.7 ( 1.36 ) 5.5 ( 1.34 ) 5.6 ( 1.3 ) -
    Subject analysis sets

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised. Note: 1 patient was excluded because underage

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the ITT population who did not experience relevant protocol violations related to the efficacy endpoint of primary interest.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who have received at least one dose of the study treatment. Note: 1 patient was excluded because underage

    Subject analysis sets values
    		 ITT population PP population Safety population
    Number of subjects
    653
    620
    653
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    653
    620
    653
        From 65-84 years
        85 years and over
    Age continuous
    Mean Age at the Informed Consent signature date
    Units: years
        arithmetic mean (standard deviation)
    26.9 ( 7.78 )
    26.9 ( 7.85 )
    26.9 ( 7.78 )
    Gender categorical
    Male and females patients could be enrolled, no rule adopted.
    Units: Subjects
        Female
    388
    369
    388
        Male
    265
    251
    265
    Pain Intensity at Qualification
    Descriptive Statistics of Pain Intensity scores at Qualification (namely within 4 hours after the end of the surgery) measured on a Numerical Rating Scale (NRS) from 0 to 10
    Units: point
        arithmetic mean (standard deviation)
    4.9 ( 1.14 )
    4.9 ( 1.15 )
    4.9 ( 1.14 )
    Pain Intensity at T-0h (baseline)
    Descriptive statistics of Pain Intensity at T-oh (baseline defined as NRS-PI assessed immediately prior to drug administration) measured on a NRS from 0 to 10
    Units: point
        arithmetic mean (standard deviation)
    5.6 ( 1.34 )
    5.6 ( 1.33 )
    5.6 ( 1.34 )

    End points

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    End points reporting groups
    Reporting group title
    Screening
    Reporting group description
    		 Screening period for study eligibility assessment
    Reporting group title
    DKP.TRIS/TRAM.HCl
    Reporting group description
    		 Dexketoprofen trometamol/Tramadol hydrochloride 25mg /75mg

    Reporting group title
    TRAM.HCl/ Paracetamol
    Reporting group description
    		 Tramadol hydrochloride/ Paracetamol 75mg/650mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching DKP.TRIS/TRAM.HCl and TRAM.HCl/Paracetamol

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised. Note: 1 patient was excluded because underage

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the ITT population who did not experience relevant protocol violations related to the efficacy endpoint of primary interest.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who have received at least one dose of the study treatment. Note: 1 patient was excluded because underage

    Primary: Total pain relief (TOTPAR6)

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    End point title
    		 Total pain relief (TOTPAR6)
    End point description
    The primary endpoint of the study was the total pain relief over 6 hours post-dose period (TOTPAR6).
    End point type
    Primary
    End point timeframe
    over 6-hour post dose period
    End point values
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo ITT population
    Number of subjects analysed
    260
    262
    131
    653
    Units: point
        arithmetic mean (standard deviation)
    13 ( 6.97 )
    9.2 ( 7.65 )
    1.9 ( 3.89 )
    9.2 ( 7.88 )
    Statistical analysis title
    		 Primary Efficacy end-point
    Comparison groups
    TRAM.HCl/ Paracetamol v DKP.TRIS/TRAM.HCl
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.025
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - The hypothesis of non-inferiority of DKP.TRIS/TRAM.HCl versus TRAM.HCl/Paracetamol was tested for both ITT and PP population by using an ANCOVA model with treatment (as main effect) and baseline PI (NRS) as covariate. 20% was set as non-inferiority limit.
    Statistical analysis title
    		 Primary efficacy endpoint
    Comparison groups
    DKP.TRIS/TRAM.HCl v TRAM.HCl/ Paracetamol
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Primary: Total pain relief (TOTPAR6)

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    End point title
    		 Total pain relief (TOTPAR6)
    End point description
    The primary endpoint of the study was the total pain relief over 6 hours post-dose period (TOTPAR6).
    End point type
    Primary
    End point timeframe
    over 6-hour post-dose
    End point values
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo PP population
    Number of subjects analysed
    246
    248
    126
    620
    Units: point
        arithmetic mean (standard deviation)
    12.9 ( 6.89 )
    9.2 ( 7.71 )
    1.9 ( 3.9 )
    9.2 ( 7.88 )
    Statistical analysis title
    		 Primary Efficacy end-point
    Comparison groups
    DKP.TRIS/TRAM.HCl v TRAM.HCl/ Paracetamol
    Number of subjects included in analysis
    494
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.025
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - The hypothesis of non-inferiority of DKP.TRIS/TRAM.HCl versus TRAM.HCl/Paracetamol was tested for both ITT and PP population by using an ANCOVA model with treatment (as main effect) and baseline PI (NRS) as covariate. 20% was set as non-inferiority limit.
    Statistical analysis title
    		 Primary efficacy endpoint
    Comparison groups
    DKP.TRIS/TRAM.HCl v TRAM.HCl/ Paracetamol
    Number of subjects included in analysis
    494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of patients achieving at least 50% of max TOTPAR at 6 hours post dose

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    End point title
    		 Percentage of patients achieving at least 50% of max TOTPAR at 6 hours post dose
    End point description
    Responders were defined as those patients having achieved at least at least 50% max TOTPAR at each pre-specified time point.
    End point type
    Secondary
    End point timeframe
    at 6 hours after the treatment intake
    End point values
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo ITT population
    Number of subjects analysed
    260
    262
    131
    653
    Units: patients
    157
    101
    5
    263
    Statistical analysis title
    		 Secondary efficacy endpoint
    Comparison groups
    DKP.TRIS/TRAM.HCl v TRAM.HCl/ Paracetamol v Placebo
    Number of subjects included in analysis
    653
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Sum of Pain Intensity Differences over 6 hours post dose (SPID 6)

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    End point title
    		 Sum of Pain Intensity Differences over 6 hours post dose (SPID 6)
    End point description
    Sum of Pain Intensity Differences, calculated as the weighted sum of the PID values, over 6 hours after treatment intake (SPID6)
    End point type
    Secondary
    End point timeframe
    over 6 hours after the treatment intake
    End point values
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo ITT population
    Number of subjects analysed
    260
    262
    131
    653
    Units: points on a scale
        arithmetic mean (standard deviation)
    18.4 ( 11.09 )
    11.7 ( 11.58 )
    1.6 ( 6.72 )
    12.3 ( 12.22 )
    Statistical analysis title
    		 Secondary efficacy endpoint
    Comparison groups
    DKP.TRIS/TRAM.HCl v TRAM.HCl/ Paracetamol v Placebo
    Number of subjects included in analysis
    653
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE were collected throughout the whole duration of the study. At each visit patients were asked a standard question to elicit medically related changes in their well-being. Abnormal laboratory findings judged as clinically significant were considered AE.
    Adverse event reporting additional description
    All the AEs were recorded in source documents and eCRF. The causality of AEs was assessed based on following algorithm: 1.certanly 2.probably 3.possibly 4.unlikely 5.not related 6.unassessable AE ranked 1,2,3,6 were considered ADR
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    DKP.TRIS/TRAM.HCl
    Reporting group description
    		 Dexketoprofen trometamol/Tramadol hydrochloride 25mg /75mg fixed dose combination oral tablet single dose

    Reporting group title
    TRAM.HCl/ Paracetamol
    Reporting group description
    		 Tramadol / Paracetamol 75mg/650mg as 2 x [37.5 mg/325 mg] fixed dose combination oral tablets single dose.

    Reporting group title
    Placebo
    Reporting group description
    		 - Placebo matching DKP.TRIS/TRAM.HCl 25mg/75 mg film-coated oral tablet - Placebo matching TRAM.HCl/Paracetamol 75mg/650mg as 2 x [37.5 mg/325 mg] film-coated oral tablets.

    Serious adverse events
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 262 (0.00%)
    0 / 131 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Syncope
    Additional description: The SAE was upgraded to “serious” by the Sponsor as per “Important Medical Event” seriousness criteria, the event, consisting in syncope of mild intensity, resolved spontaneously. The event was assessed as “not related” to the study medication.
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 262 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 DKP.TRIS/TRAM.HCl TRAM.HCl/ Paracetamol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 260 (18.08%)
    54 / 262 (20.61%)
    20 / 131 (15.27%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 260 (0.77%)
    0 / 262 (0.00%)
    3 / 131 (2.29%)
         occurrences all number
    2
    0
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 260 (2.69%)
    13 / 262 (4.96%)
    0 / 131 (0.00%)
         occurrences all number
    7
    13
    0
    Somnolence
         subjects affected / exposed
    8 / 260 (3.08%)
    5 / 262 (1.91%)
    1 / 131 (0.76%)
         occurrences all number
    8
    5
    1
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    3 / 260 (1.15%)
    8 / 262 (3.05%)
    4 / 131 (3.05%)
         occurrences all number
    3
    8
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    10 / 260 (3.85%)
    12 / 262 (4.58%)
    0 / 131 (0.00%)
         occurrences all number
    10
    12
    0
    Vomiting
         subjects affected / exposed
    11 / 260 (4.23%)
    14 / 262 (5.34%)
    0 / 131 (0.00%)
         occurrences all number
    11
    14
    0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    8 / 260 (3.08%)
    2 / 262 (0.76%)
    2 / 131 (1.53%)
         occurrences all number
    8
    2
    2

    More information

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

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