E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neurogenic detrusor overactivity.
Hiperactividad neurogénica del detrusor |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012547 |
E.1.2 | Term | Detrusor hyperreflexia |
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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 assess the efficacy of solifenacin 10mg compared to placebo in patients with neurogenic detrusor overactivity
Evaluar la eficacia de 10 mg de solifenacina en comparación con placebo en pacientes con hiperactividad neurogénica del detrusor |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of solifenacin 5mg compared to placebo in patients with neurogenic detrusor overactivity To assess the efficacy of solifenacin compared to oxybutynin in patients with neurogenic detrusor overactivity To assess the safety and tolerability of solifenacin compared to placebo in patients with neurogenic detrusor overactivity To assess the safety and tolerability of solifenacin compared to oxybutynin in patients with neurogenic detrusor overactivity Evaluar la eficacia de 5 mg de solifenacina en comparación con placebo, evaluar la eficacia de solifenacina en comparación con oxibutinina, evaluar la seguridad y tolerabilidad de solifenacina en comparación con placebo y evaluar la seguridad y tolerabilidad de solifenacina en comparación con oxibutinina en pacientes con hiperactividad neurogénica del detrusor
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects aged 18 years or over. 2. Written informed consent. 3. Subjects with neurogenic detrusor overactivity due to multiple sclerosis (MS) (EDSS≤8) or spinal cord injury (SCI) (partial and complete lesions) 4. MS or SCI symptoms stable for 6 months or more. 5. Neurogenic detrusor overactivity symptoms stable for 6 months or more. 6. Subject is willing and able to perform clean, intermittent, catheterization, if required.
1. Varón o mujer con una edad ≥18 años. 2. Consentimiento informado por escrito para participar en el estudio. 3. Pacientes con hiperactividad neurogénica del detrusor debido a: Esclerosis múltiple (EM) (EDSS ≤8) ó Lesión Medular (LME) (lesiones parciales o completas) 4. Los síntomas de EM o LME deben ser estables durante al menos 6 meses 5. Los síntomas de hiperactividad neurogénica del detrusor deben ser estables durante al menos 6 meses. 6. El paciente es capaz y está dispuesto a sondarse por si mismo o asistido de forma limpia e intermitente, si fuese necesario.
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E.4 | Principal exclusion criteria |
1. Neurogenic detrusor overactivity due to Parkinson’s or cerebrovascular disease. 2. Sjögren’s Syndrome or any similar symptoms. 3. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs. 4. Stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator. 5. Evidence of pressure sores grade 2 or more. 6. History of bladder sphincterotomy. 7. Known history of vesico-ureteral reflux without upper urinary tract infection. 8. Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber. 9. Undergoing haemodialysis. 10. Severe hepatic impairment. 11. Concurrent use of drugs intended to treat overactive bladder symptoms. 12. Use of antidepressants or muscle relaxants which have not been administered at a constant dose for 3 months or more. 13. Use of non-drug treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin and vanilliods therapy in the six months prior to the commencement of the study. 14. Use of permanent, indwelling catheters. 15. Known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose. 16. Concomitant use of a strong CYP3A4 inhibitor, e.g. Ketoconazole. 17. Pregnant women, women who intend to become pregnant during the study, women of childbearing potential who are sexually active and practicing an unreliable method of birth control or women who will be lactating during the study. 20. Maximum bladder capacity 400 ml or more.
1. Pacientes con hiperactividad neurogénica del detrusor debido a enfermedad de Parkinson o a una enfermedad cerebrovascular 2. Pacientes con síndrome de Sjögren o síntomas similares. 3. Pacientes con evidencia de infección sintomática de las vías urinarias, inflamación crónica como la cistitis intersticial, cálculos vesicales, radioterapia pélvica previa o patología maligna previa o actual de los órganos pélvicos 4. Pacientes con incontinencia de esfuerzo o mixta en la que el esfuerzo es el factor predominante, a juicio del investigador. 5. Pacientes con evidencia de úlceras de presión grado 2 o superior 6. Pacientes con historial de esfinterotomía vesical 7. Pacientes con historia conocida de reflujo vesicoureteral sin infección de las vías urinarias superiores 8. Cualquier afección clínicamente significativa que, en opinión del investigador, haga que el paciente no sea apto para el estudio o incluya antecedentes de retención urinaria aguda, obstrucción gastrointestinal grave (incluido el íleo paralítico o atonía intestinal), procesos gastrointestinales graves (incluido el megacolon tóxico o la colitis ulcerosa), miastenia gravis, glaucoma de ángulo estrecho o inflamación de la cámara anterior. estrecha. 9. Pacientes sometidos a hemodiálisis 10. Pacientes con insuficiencia hepática grave 11. Uso concomitante de fármacos para tratamiento de los síntomas de la vejiga hiperactiva 12. Utilización de antidepresivos o relajantes musculares que no se hayan administrado a una dosis constante durante al menos 3 meses. 13. Administración de tratamiento no farmacológico para los síntomas de la vejiga hiperactiva, incluida la terapia de electroestimulación, la toxina botulínica y la terapia con vaniloides en los seis meses previos al comienzo del estudio 14. Utilización de sondas permanentes 15. Hipersensibilidad conocida o sospechada frente a succinato de solifenacina, oxibutinina clorhidrato, otro anticolinérgico o lactosa. 16. Uso concomitante de un inhibidor potente del CYP3A4, como el ketoconazol. 17. Mujeres embarazadas; o mujeres que deseen quedarse embarazadas durante el estudio; o mujeres en edad fértil, sexualmente activas y que utilicen un método anticonceptivo poco fiable; o mujeres en periodo de lactancia durante el estudio. Los métodos anticonceptivos fiables son los dispositivos intrauterinos, las píldoras anticonceptivas de tipo combinación, los implantes hormonales y los anticonceptivos inyectables. 20. Pacientes con una capacidad vesical máxima ≥400 ml
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to end point in maximum cystometric capacity.
Cambio respecto al valor basal en la capacidad cistomanométrica máxima. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Last visit of last subject undergoing the trial.
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |