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    Clinical Trial Results:
    Use of tramadol in healthy volunteers. Effects on physical performance and sustained attention in cycling.

    Summary
    EudraCT number
    		 2015-005056-96
    Trial protocol
    		 ES  
    Global end of trial date
    02 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2021
    First version publication date
    24 Jun 2021
    Other versions
    Summary report(s)
    		 Results report
    Dataset Cohort 1
    Data Set Cohort 2

    Trial information

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    Trial identification
    Sponsor protocol code
    TRAWADA2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centro de investigación mente cerebro y comportamiento
    Sponsor organisation address
    Campus de la Cartuja s/n, Granada, Spain, 18011
    Public contact
    Emilio García Cabrera, Delos Clinical, 0034 655843699, emiliogcabrera@delosclinical.com
    Scientific contact
    Emilio García Cabrera, Delos Clinical, 0034 655843699, emiliogcabrera@delosclinical.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
    28 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of an acute dose of tramadol compared to placebo, in the physical and cognitive performance in cyclists
    Protection of trial subjects
    Incidencia de acontecimientos adversos (AA)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 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
    Spain: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Tramadol
    Arm description
    		 Capsulas de gelatina dura, numero 0 de color rojo que contienen 2 capsulas de 50 mg de tramadol EFG.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRAMADOL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsulas de gelatina dura, numero 0 de color rojo que contienen 2 capsulas de 50 mg de tramadol EFG.

    Arm title
    		 Placebo
    Arm description
    		 Capsulas de gelatina dura, numero 0 de color rojo que contienen 100mg de hidroxipropilmetilcelulosa
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cápsulas de gelatina dura, numero 0 de color rojo que contienen 100mg de hidroxipropilmetilcelulosa

    Number of subjects in period 1
    		Tramadol Placebo
    Started
    60
    60
    Completed
    57
    57
    Not completed
    3
    3
         Adverse event, non-fatal
    2
    2
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Baseline period

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 60 60
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25 ( 6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 50 50
    Subject analysis sets

    Subject analysis set title
    Cohorte 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy volunters

    Subject analysis set title
    Cohorte 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Professional cyclist

    Subject analysis sets values
    		 Cohorte 1 Cohorte 2
    Number of subjects
    28
    29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    30
    30
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    25 ( 7 )
    25 ( 5 )
    Gender categorical
    Units: Subjects
        Female
    10
    0
        Male
    20
    30

    End points

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    End points reporting groups
    Reporting group title
    Tramadol
    Reporting group description
    		 Capsulas de gelatina dura, numero 0 de color rojo que contienen 2 capsulas de 50 mg de tramadol EFG.

    Reporting group title
    Placebo
    Reporting group description
    		 Capsulas de gelatina dura, numero 0 de color rojo que contienen 100mg de hidroxipropilmetilcelulosa

    Subject analysis set title
    Cohorte 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy volunters

    Subject analysis set title
    Cohorte 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Professional cyclist

    Primary: Rendimiento físico

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    End point title
    		 Rendimiento físico
    End point description
    La evaluación de rendimiento físico, se realizará mediante la diferencia de medias del umbral de potencia funcional (UPF). Se ha definido como la potencia media más alta que puede mantener durante 1 hora aproximadamente (Allen & Coggan, 2010). Cuando se mide correctamente, UPF es una intensidad que es similar al umbral de lactato en sangre, que a su vez se ha encontrado que es altamente predictivo del rendimiento en eventos y distancias de resistencia (Faude et al., 2009). Se evaluará la diferencia de la potencia media entre las dos condiciones que presentará el paciente, con tratamiento de tramadol y de placebo.
    End point type
    Primary
    End point timeframe
    30 min
    End point values
    		 Cohorte 1 Cohorte 2
    Number of subjects analysed
    28
    29
    Units: UPF
    28
    29
    Statistical analysis title
    		 Main objective analysis
    Comparison groups
    Cohorte 1 v Cohorte 2
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days
    Adverse event reporting additional description
    pacientes fueron de la cohorte 1 (30%), y 4 (13,3%) fueron de la cohorte 2. Del total de 27 acontecimientos adversos, todos (100%) fueron acontecimientos adversos no graves. El 96,3% (26/27) se produjeron en los pacientes cuando tomaron tramadol y fueron relacionados con la medicación a estudio.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7
    Reporting groups
    Reporting group title
    Cohorte 1
    Reporting group description
    		 -

    Reporting group title
    Cohorte 2
    Reporting group description
    		 -

    Serious adverse events
    		 Cohorte 1 Cohorte 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 29 (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: 0%
    Non-serious adverse events
    		 Cohorte 1 Cohorte 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 28 (28.57%)
    3 / 29 (10.34%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 28 (25.00%)
    3 / 29 (10.34%)
         occurrences all number
    7
    3
    Somnolence
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 29 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 29 (3.45%)
         occurrences all number
    5
    1
    Abdominal pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0

    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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