Clinical trial on the effects of the tramadol and paracetamol on physical, cognitive and brain performance during cycling

Phase 1

• Conditions: Sports doping; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2018-000388-10-ES
• Lead Sponsor: Daniel Sanabria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified