E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Assess whether there is a clinically significant reduction in intraoral bone exposure (measured in mm) in the experimental group after the start of treatment with pentoxifylline and tocopherol (PENTO) for a minimum of 6 months and a maximum of 18 months compared to the control group that will continue to make the standard treatment currently being undertaken in the service of CMF's Vall d'Hebron Hospital. |
Evaluar clínicamente si existe una disminución significativa de la exposición ósea intraoral (calculada en mm) en el grupo experimental tras el inicio del tratamiento con Pentoxifilina y Tocoferol (PENTO) durante un mínimo de 6 meses y un máximo de 18 meses con respecto al grupo control que continuará realizando el tratamiento estándar que se realiza actualmente en el servicio de CMF del Hospital Vall d'Hebrón. |
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E.1.1.1 | Medical condition in easily understood language |
Clinical evolution of mandibular osteoradionecrosis |
Evolución clínica de la osteoradionecrosis mandibular |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
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 |
Healing of mandibular osteoradionecrosis in patients irradiated for head and neck cance after treatment with Pentoxifilina and Tocopherol (PENTO) |
Curación de la osteoradionecrosis mandibular en pacientes que han sido irradiados por cancer de cabeza y cuello tras el tratamiento con Pentoxifilina y Tocoferol (PENTO). |
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E.2.2 | Secondary objectives of the trial |
Subjective analysis by SOMA scale (Subjective Objective Management and Analytic evaluation of injury). Differences in the clinical stage of ORN according to the WHO classification (2009) after treatment with PENTO. |
Análisis subjetivo mediante la escala SOMA (Subjective Objective Management and Analytic evaluation of injury). Diferencias en el estadio clínico de la ORN según la clasificación de la OMS (2009) tras el tratamiento con PENTO |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
symptoms of mandibular osteoradionecrosis in patients irradiated for head and neck cancer |
sintomas de osteoradionecrosis mandibular en pacientes irradiados por cancer de cabeza y cuello |
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E.4 | Principal exclusion criteria |
patients who are at a stage III in the classification of the mandibular osteoradionecrosis and require reconstructive surgery. |
pacientes que se encuentren en un estadio III en la clasificación de la osteoradionecrosis mandibular y que requieran cirugia reconstructiva. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Decreased intraoral bone exposure (mm) |
Disminución de la exposición ósea intraoral (mm) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
It will be assessed during clinic visits at this months: M0, M1, M3, M6, M9, M12, M18. |
Se evaluará durante las visitas clínicas realizadas en los meses: M0, M1, M3, M6, M9, M12, M18. |
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E.5.2 | Secondary end point(s) |
Subjective analysis by SOMA scale (Subjective Objective Management and Analytic evaluation of injury). Improvement in the clinical stage of ORN according to the WHO classification (2009) after treatment with PENTO. |
Análisis subjetivo mediante la escala SOMA (Subjective Objective Management and Analytic evaluation of injury). Mejoría del estadio clínico de la ORN según la clasificación de la OMS (2009) tras el tratamiento con PENTO. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
It will be assessed during clinic visits at this months: M0, M1, M3, M6, M9, M12, M18. |
Se evaluará durante las visitas clínicas realizadas en los meses: M0, M1, M3, M6, M9, M12, M18. |
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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 | Yes |
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 | 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) | 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 |
Tratamiento médico estándar |
standard medical treatment. |
|
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
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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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |