E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immobilized subjects. |
Sujetos inmovilizados. |
|
E.1.1.1 | Medical condition in easily understood language |
Immobilized patients |
Pacientes inmovilizados. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
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 |
Determining the effect of allopurinol administration on the prevention of loss of muscle mass in immobilized subjects. In this way we aim to determine the role of xanthine oxidase in free radical production in skeletal muscle during a period of immobilization |
Determinación del efecto de la administración de alopurinol sobre la prevención de la pérdida de masa muscular en sujetos inmovilizados. De este modo pretendemos determinar el papel de la xantina oxidasa en la producción de radicales libres en el músculo esquelético durante un periodo de inmovilización |
|
E.2.2 | Secondary objectives of the trial |
To determine the effect of allopurinol administration on the size of the muscles of the leg in a group of subjects immobilized for a period of 15 days. To determine the effect of allopurinol administration on the loss of muscle strength of leg muscles in a group of subjects immobilized for a period of 15 days. To determine the effect of allopurinol administration on various parameters of systemic oxidative stress (GSH, GSSG, MDA and oxidized proteins) and plasma activity of xanthine oxidase, after a period of immobilization of 15 days |
Determinar el efecto de la administración de alopurinol sobre el tamaño de la musculatura de la pierna en un grupo de sujetos inmovilizados durante un periodo de 15 días. Determinar el efecto de la administración de alopurinol sobre la pérdida de fuerza muscular de la musculatura de la pierna en un grupo de sujetos inmovilizados durante un periodo de 15 días. Determinar el efecto de la administración de alopurinol sobre distintos parámetros de estrés oxidativo sistémico (GSH, GSSG, MDA y proteínas oxidadas), así como la actividad plasmática de la xantina oxidasa, tras un periodo de inmovilización de 15 días de duración |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with grade II sprain. Males. Ages 20 to 40 years. Patients not taking regular medication. The concept is understood not to take regular medication to all patients who chronically fail to take any medication in a timely manner regardless of whether they needed to take the last week or last month for a condition treatment on time. All patients must have written full informed consent specifically for this study |
Pacientes con esguince de grado II. Varones. Edad de 20 a 40 años. Paciente que no tomen medicación habitual. Se entiende el concepto que no tomen medicación habitual a todos aquellos paciente que no tomen de forma crónica algún tipo de medicamento independientemente que de forma puntual hayan necesitado tomar la semana pasada o el més anterior un tratamiento para una dolencia puntual. Todos los pacientes deben presentar por escrito el consentimiento informado completo específico para este estudio. |
|
E.4 | Principal exclusion criteria |
Liver and gastrointestinal disease. Hipotiroismo untreated. Alcohol and / or substance abuse. Vitamin supplements. Eating disorders. Drugs that lower lipid levels. Hypotensive drugs. Smokers. Athletes who perform strenuous exercise. Mental disorders, depression or anxiety intensity. These diseases cause the patient unable to understand the nature or scope and possible consequences of the study. Patients with any infectious process and / or inflammatory before collecting the sample. Patients may not follow the protocol because of its lack of cooperation, inability to return to subsequent visits and there is little chance of completing the study procedures. Hypersensitivity to allopurinol. |
Enfermedad hepática y gastrointestinal. Hipotiroismo no tratado. Alcoholismo y/o drogadicción. Suplementos vitamínicos. Trastornos alimenticios. Fármacos que disminuyen la concentración de lípidos. Fármacos hipotensores. Fumadores. Deportistas que realizan ejercicio intenso. Trastornos mentales, depresión o ansiedad de gran intensidad. Estas enfermedades hacen al paciente incapaz de comprender la naturaleza o el ámbito y las posibles consecuencias del estudio. Pacientes que presenten algún proceso infeccioso y/o inflamatorio antes de la recogida de la muestra. Pacientes que probablemente no seguirán el protocolo debido a su falta de cooperación, a su incapacidad para volver a las visitas posteriores y a la poca posibilidad que existe de que completen los procedimientos del estudio. Hipersensibilidad conocida al Alopurinol. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine the role of xanthine oxidase in free radical production in skeletal muscle during a period of immobilization. |
Determinar el papel de la xantina oxidasa en la producción de radicales libres en el músculo esquelético durante un periodo de inmovilización. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During a period of immobilization. |
Durante el periodo de inmovilización. |
|
E.5.2 | Secondary end point(s) |
Determinar el efecto de la administración de alopurinol sobre el tamaño de la musculatura de la pierna en un grupo de sujetos inmovilizados durante un periodo de 15 días. Determinar el efecto de la administración de alopurinol sobre la pérdida de fuerza muscular de la musculatura de la pierna en un grupo de sujetos inmovilizados durante un periodo de 15 días. Determinar el efecto de la administración de alopurinol sobre distintos parámetros de estrés oxidativo sistémico (GSH, GSSG, MDA y proteínas oxidadas), así como la actividad plasmática de la xantina oxidasa, tras un periodo de inmovilización de 15 días de duración. |
To determine the effect of allopurinol administration on the size of the muscles of the leg in a group of subjects immobilized for a period of 15 days. To determine the effect of allopurinol administration on the loss of muscle strength of leg muscles in a group of subjects immobilized for a period of 15 days. To determine the effect of allopurinol administration on various parameters of systemic oxidative stress (GSH, GSSG, MDA and oxidized proteins) and plasma activity of xanthine oxidase, after a period of immobilization of 15 days) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For a period of 15 days. |
Durante un periodo de 15 días. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
New indications. |
Nuevo indicaciones. |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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
|
One month after withdrawing the drug |
Un mes tras la retirada del fármaco. |
|
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 |