E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sport doping |
Dopaje deportivo |
|
E.1.1.1 | Medical condition in easily understood language |
Sport doping |
Dopaje deportivo |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076471 |
E.1.2 | Term | Drug doping |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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 |
Comprobar el efecto de una dosis aguda de tramadol, en comparación con placebo, en el rendimiento físico y cognitivo en ciclistas |
|
E.2.2 | Secondary objectives of the trial |
1. Evaluate the effect of tramadol versus placebo in physiological indices and subjective related to cycling performance.
2. Evaluate the effects of tramadol versus placebo in sustained attention at basal status.
3. Assess the effects of tramadol versus placebo in sustained attention in an effort to functional threshold power cycling. |
1. Evaluar el efecto del tramadol frente a placebo en índices fisiológicos y subjetivos relacionados con el rendimiento en ciclismo. 2. Evaluar los efectos del tramadol frente a placebo en atención sostenida en reposo. 3. Evaluar los efectos del tramadol frente a placebo en atención sostenida durante un esfuerzo al umbral de potencia funcional en ciclismo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed informed consent before any activity related with the study, including assessments required for the selection.
- Age between 18 and 35 years inclusive.
- If women would find no confirmation pregnant or breastfeeding and commitment to use adequate contraception as hormonal contraception, intrauterine device or barrier methods (vaginal condom or diaphragm) along the entire study period. |
- Firma del consentimiento informado antes de cualquier actividad relacionada con el estudio, incluidas las evaluaciones necesarias para la selección. - Edad comprendidas entre 18 y 35 años ambos inclusive. - En caso de mujeres, confirmación de no encontrase embarazada ni en lactancia, y compromiso de uso de un método anticonceptivo adecuado como contracepción hormonal, dispositivo intrauterino o métodos barrera (preservativo o diafragma vaginal) a lo largo de todo el periodo del estudio. |
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E.4 | Principal exclusion criteria |
- Allergy to tramadol or any of the excipients - Any symptoms of heart disease - Metabolic disorder such as obesity (BMI> 30) or diabetes - Chronic obstructive pulmonary disease (COPD) - Epilepsy or seizure risk as withdrawal - Active treatment with beta-blockers - Patients treated with MAO inhibitors or that they have received Over the past 14 days - Consumption of alcohol, snuff or other drugs of abuse that could incapacitate to participate in the study. - Diagnosis of any other condition that the investigator's opinion, may increase the risk of the subject or reduce the chances of obtaining data satisfactory to achieve the objectives of the study. |
- Alergia a tramadol 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
- Pacientes 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained attention test |
Test de atención sostenida |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Heart Rate - VO2 - VCO2 - Cerebral activity - Subjetive performance |
- Frecuencia cardíaca - Intercambio gaseoso - Actividad cerebral - Rendimiento subjetivo |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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 paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |