E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fibromyalgia |
Fibromialgia |
|
E.1.1.1 | Medical condition in easily understood language |
Fibromyalgia |
Fibromialgia |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048439 |
E.1.2 | Term | Fibromyalgia |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 efficacy of coenzyme Q10 versus placebo in patients diagnosed with fibromyalgia in terms of clinical response measured by means of the Fibromyalgia Impact Questionnaire (FIQ) |
Comparar la eficacia de coenzima Q10 con respecto a placebo en pacientes diagnosticados de FM, en términos de respuesta clínica medida por el Fibromyalgia Impact Questionnaire (FIQ). |
|
E.2.2 | Secondary objectives of the trial |
To compare the efficacy of coenzyme Q10 versus placebo in terms of clinical response measured by means of the Visual Analogue Scale (VAS)
To assess the safety of coenzyme Q10 administered orally |
- Evaluar comparativamente la eficacia del coenzima Q10con respecto a placebo en pacientes diagnosticados de FM, en términos de respuesta clínica medida por la Escala Visual Analógica del dolor (EVA).
- Evaluar la seguridad de la administración oral del coenzima Q10. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female between 18 and 65 years of age
Patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 criteria |
1. Pacientes de ambos sexos, pertenecientes al grupo de edad: ?18 y ?65 anos.
2. Pacientes con diagnóstico de confirmación de fibromialgia, según los criterios del American College of Rheumatology 2010.
3. Pacientes que firmen el consentimiento informado, aceptando participar en el estudio. |
|
E.4 | Principal exclusion criteria |
1.- Patients diagnosed with rheumatologic diseases: rheumatoid artritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erytematosus, crystalline arthritis or osteoarthrosis.
2.- Severe systemic diseases, including cardiopulmonary, neurologic, renal or infectious diseases or any other condition that may affect the study
3.- Patients with severe mental disorders (psychotic, depressive or maniac disorders, suicide attempt, toxic abuse, and/or any psychical or physical disorders
4.- Patients receiving Coenzyme Q10, antidepressants, statins or tramadol
4.- Patients with pain due to other chronic diseases
5.- Pregnant and breastfeeding women. |
1. Pacientes con patología reumática concomitante: artritis reumatoide, espondilitis anquilosante, artritis psoriásica, lupus eritematoso sistémico, artropatías micro cristalinas o artrosis.
2. Enfermedad sistémica grave: cardio-pulmonar, neurológica, renal, infecciosa o de cualquier otro tipo que pueda impedir el desarrollo del estudio o evaluación de los resultados.
3. Pacientes con trastorno mental grave (trastorno psicótico, riesgo de autolisis, episodio maniaco), dependencia de sustancias toxicas y/o alguna limitación física o psíquica para contestar.
4. Pacientes en tratamiento con coenzima Q10, antidepresivos, estatinas y/o tramadol.
5. Pacientes en litigio por reclamación de invalidez relacionado o no con la enfermedad.
6. Pacientes que no puedan acudir a las visitas necesarias para llevar a cabo el estudio.
7. Pacientes que tengan dolor crónico de origen distinto a la FM.
8. Pacientes que se nieguen a participar o a firmar el consentimiento informado.
9. Embarazo y lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Differences between Fibromyalgia Impact Questionnaire (FIQ) scores at week 12 and baseline |
Diferencia en la puntuación obtenida a los tres meses de tratamiento en el Fibromyalgia Impact Questionnaire (FIQ), versión española, con respecto a la línea basal. Se considerara la diferencia clínica y estadísticamente significativa en un cambio de 10 puntos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Differences between Visual Analogue Scale (VAS) at week 12 and baseline
Plasmatic and intracellular level of coenzyme Q10 and malondialdehyde at baseline and at week 12
Use of any pharmacologic agent to treat pain
Use of alternative therapies
Adverse events |
Diferencia en la puntuación obtenida a los tres meses de tratamiento con respecto a la línea basal en la Escala Visual Analógica para el dolor (EVA).
Niveles de coenzima Q10y del biomarcador de estrés oxidativo malondialdehido al inicio y a los 3meses de tratamiento.
Tratamiento farmacológico concomitante (principio activo, vía de administración, dosis, pauta).
Terapias alternativas (plantas medicinales; ejercicio físico, terapia cognitiva conductual, acupuntura, otras).
Acontecimientos adversos (AA).
Constantes vitales |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
|
last visit of the last subject |
ültima visita del último sujeto |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |