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    Clinical Trial Results:
    A randomised, interventional, double blind, crossover, controlled study to assess the effect of the administration of paracetamol on tramadol adverse events.

    Summary
    EudraCT number
    		 2017-002668-42
    Trial protocol
    		 BG  
    Global end of trial date
    14 Feb 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    TRA-IV-17-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratoires SMB S.A.
    Sponsor organisation address
    26-28, rue de la Pastorale, Brussels, Belgium, 1080
    Public contact
    Clinical Department, Laboratoires SMB S.A., 0032 24114828, Dpt_Clinique@smb.be
    Scientific contact
    Clinical Department, Laboratoires SMB S.A., 0032 24114828, Dpt_Clinique@smb.be
    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 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of paracetamol on the tramadol safety profile.
    Protection of trial subjects
    For this study, no specific measures were put in place to protect trial subjects. The study treatments (Tramadol & Paracetamol) were two products marketed by the Laboratoires SMB since many years and then were well known by most of the participating subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 2017
    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
    Bulgaria: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    150
    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 one center in Bulgaria. The subject recruitment was adequate to meet the target enrolment goal of 150 subjects. After the screening visit, the subjects were randomized in one of the two sequences of treatment and stayed in the study for a minimum of 11 days.

    Pre-assignment
    Screening details
    		 -Obtain signed ICF - Obtain demographic data -Perform a medical history and a physical examination -Take vital signs -Review prior/concomitant médications _Perform laboratory assessments: haematology, chemistry, and pregnancy test -Review inclusion/exclusion criteria

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Tramadol + Placebo
    Arm description
    		 The subjects received tramadol + placebo during two consecutive days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet for oral use containing only the excipients of the active substance (Paracetamol). One tablet was taken three times per day (T0, T6, T12) on day 1 and 2 of the period.

    Investigational medicinal product name
    Tramadol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tramium (Tramadol) prolonged release capsule for oral use containing 200 mg of tramadol chlorhydrate. One capsule was taken once a day on day 1 and 2 of the period.

    Arm title
    		 Tramadol + Paracetamol
    Arm description
    		 The subjects received tramadol + paracetamol during two consecutive days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paracetamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paracetamol (Algostase Mono) tablet for oral use containing 500 mg of paracetamol. One tablet was taken three times per day (T0, T6, T12) on day 1 and 2 of the period.

    Investigational medicinal product name
    Tramadol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tramium (Tramadol) prolonged release capsule for oral use containing 200 mg of tramadol chlorhydrate. One capsule was taken once a day on day 1 and 2 of the period.

    Number of subjects in period 1
    		Tramadol + Placebo Tramadol + Paracetamol
    Started
    149
    150
    Completed
    149
    149
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cross over phase
    Reporting group description
    		 -

    Reporting group values
    		 Cross over phase Total
    Number of subjects
    		 150 150
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 150 150
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.91 ± 12.06 -
    Gender categorical
    Units: Subjects
        Female
    		 86 86
        Male
    		 64 64

    End points

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    End points reporting groups
    Reporting group title
    Tramadol + Placebo
    Reporting group description
    		 The subjects received tramadol + placebo during two consecutive days.

    Reporting group title
    Tramadol + Paracetamol
    Reporting group description
    		 The subjects received tramadol + paracetamol during two consecutive days.

    Primary: Adverse Events

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    End point title
    		 Adverse Events
    End point description
    End point type
    Primary
    End point timeframe
    Adverse event reporting started from signature of the subject informed consent form and ended by a phone call 7 days (+-1 day) after the last visit at site.
    End point values
    		 Tramadol + Placebo Tramadol + Paracetamol
    Number of subjects analysed
    149
    150
    Units: number
    116
    85
    Statistical analysis title
    		 Descriptive statistics
    Comparison groups
    Tramadol + Placebo v Tramadol + Paracetamol
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE reporting started from signature of the subject informed consent form and ended by a phone call 7 days (+- 1 day) after the last day at site.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Tramadol + Paracetamol
    Reporting group description
    		 -

    Reporting group title
    Tramadol + Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Tramadol + Paracetamol Tramadol + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 149 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tramadol + Paracetamol Tramadol + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 150 (30.00%)
    56 / 149 (37.58%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    20 / 150 (13.33%)
    18 / 149 (12.08%)
         occurrences all number
    22
    20
    Headache
         subjects affected / exposed
    10 / 150 (6.67%)
    12 / 149 (8.05%)
         occurrences all number
    11
    13
    Somnolence
         subjects affected / exposed
    9 / 150 (6.00%)
    8 / 149 (5.37%)
         occurrences all number
    10
    9
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    8 / 150 (5.33%)
    7 / 149 (4.70%)
         occurrences all number
    10
    7
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 150 (5.33%)
    8 / 149 (5.37%)
         occurrences all number
    8
    8
    Vomiting
         subjects affected / exposed
    12 / 150 (8.00%)
    29 / 149 (19.46%)
         occurrences all number
    17
    53

    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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