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    Summary
    EudraCT Number:2018-000388-10
    Sponsor's Protocol Code Number:WADA_17C09
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000388-10
    A.3Full title of the trial
    Clinical trial on the effects of the tramadol and paracetamol on physical, cognitive and brain performance during cycling
    Efecto del tramadol y el paracetamol sobre el rendimiento físico, cognitivo y cerebral durante el
    ciclismo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial on the effects of the tramadol and paracetamol on physical, cognitive and brain performance during cycling
    Efecto del tramadol y el paracetamol sobre el rendimiento físico, cognitivo y cerebral durante el
    ciclismo
    A.4.1Sponsor's protocol code numberWADA_17C09
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaniel Sanabria
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportWorld Anti-Doping Agency (WADA)
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBAO
    B.5.2Functional name of contact pointSARAH BIEL
    B.5.3 Address:
    B.5.3.1Street AddressAVD DE MADRID, 15
    B.5.3.2Town/ cityGRANADA
    B.5.3.3Post code18012
    B.5.3.4CountrySpain
    B.5.6E-mailsbiel@fibao.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TRAMADOL NORMON 50 mg Cápsulas EFG
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAMADOL
    D.3.9.3Other descriptive nameTRAMADOL
    D.3.9.4EV Substance CodeSUB11210MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Efferalgan 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARACETAMOL
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sports doping
    Dopaje deportivo
    E.1.1.1Medical condition in easily understood language
    Sports doping
    Dopaje deportivo
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to verify the effect of an acute dose of tramadol, compared to an acute dose of paracetamol and compared to placebo, on physical and cognitive performance in cyclists
    El objetivo de este estudio es comprobar el efecto de una dosis aguda de tramadol, en comparación con una dosis aguda de paracetamol y en comparación con placebo, en el rendimiento físico y cognitivo en ciclistas
    E.2.2Secondary objectives of the trial
    1. To investigate the effect of tramadol vs. paracetamol vs. placebo on physiological and subjective parameters related to cycling performance (1st and 2nd year).
    2. To investigate the effect of tramadol vs. paracetamol vs. placebo on sustained attention (at the cognitive and brain levels) during cycling performance at constant load and during a self-paced indoor time trial (both on objective and subjective performance parameters) (1st and 2nd year).
    3. To investigate the effect of tramadol vs. paracetamol vs. placebo on cycling performance during short maximal intensity efforts (1st and 2nd year) using repeated 30 seconds Wingate cycling tests.
    1. Investigar el efecto de tramadol vs. paracetamol versus placebo en los parámetros fisiológicos y subjetivos relacionados con el rendimiento en el ciclismo.
    2. Investigar el efecto de tramadol vs. paracetamol versus placebo en la atención sostenida (a nivel cognitivo y cerebral) durante el rendimiento de ciclismo a carga constante y durante una prueba contrarreloj interna a ritmo propio (tanto en parámetros de rendimiento subjetivos como objetivos).
    3. Investigar el efecto de tramadol vs. paracetamol versus placebo en el rendimiento de ciclismo durante los esfuerzos de intensidad máxima corta usando repetidos ensayos de ciclismo de Wingate de 30 segundos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To ensure the high-fit quality profile of the participants, male cyclists and triathletes with a above average of 90 percentile, according to normative values proposed by the American College of Sports Medicine, (16) will be recruited. Age will range from 18 to 40 years. -Signature of prior consent before any activity related to the study, including the necessary evaluations for the selection.
    Para garantizar el perfil de alta calidad de los participantes, se reclutarán ciclistas y triatletas masculinos con un promedio superior al percentil 90, de acuerdo con los valores normativos propuestos por el Colegio Americano de Medicina del Deporte. La edad oscilará entre 18 y 40 años. Firma del consentimiento informado antes de cualquier actividad relacionada con el estudio, incluidas las evaluaciones necesarias para la selección.
    E.4Principal exclusion criteria
    Any selected subject that meets at least one of the following exclusion criteria may not be included in the study:
    - Allergy to tramadol or any of its excipients
    - Allergy to paracetamol or any of its excipients
    - Presence of any heart disease symptom
    - Metabolic disorder such as obesity (BMI> 30) or diabetes
    - Chronic obstructive pulmonary disease (COPD)
    - Epilepsy or risk of seizures, such as withdrawal syndrome
    - Active treatment with ß-blockers
    - Subjects under treatment with MAO inhibitors or who have received them during the last 14 days
    - Consumption of alcohol, tobacco or any other drug of abuse that could incapacitate him to participate in the study.
    - Diagnosis of any other pathology that, in the opinion of the investigator, may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.
    Cualquier sujeto seleccionado que cumpla al menos uno de los siguientes criterios de exclusión no podrá ser incluido en el estudio:
    - Alergia a tramadol o alguno de sus excipientes
    - Alergia a paracetamol o alguno de sus excipientes
    - Presencia de cualquier síntoma de cardiopatía
    - Desorden metabólico como obesidad (IMC >30) o diabetes
    - Enfermedad pulmonar obstructiva crónica (EPOC)
    - Epilepsia o riesgo de sufrir convulsiones, como el síndrome de abstinencia
    - Tratamiento activo con ß-bloqueantes
    - Sujetos bajo tratamiento con inhibidores de la MAO o que los han recibido en el transcurso de los últimos 14 días
    - Consumo de alcohol, tabaco o cualquier otra droga de abuso que pudiera incapacitarlo para participar en el estudio.
    - Diagnóstico de cualquier otra patología que, a juicio del investigador, pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Recruitment
    Pilot
    Data collection
    Data Analysis
    Reclutamiento
    Piloto
    Recolección de datos
    Análisis de datos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recruitment, month 13
    Pilot, month 6
    Data collection, month 18
    Data Analysis, month 24
    Reclutamiento, mes 13
    Piloto, mes 6
    Recolección de datos, mes 18
    Análisis de datos, mes 24
    E.5.2Secondary end point(s)
    There are no secondary end points
    No hay puntos finales secundarios
    E.5.2.1Timepoint(s) of evaluation of this end point
    There are no secondary end points
    No hay puntos finales secundarios
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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