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- Ensayo clínico NCT01167257
Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
Comparative Study of the Efficacy and Safety of Liposome Encapsulated Botulinum Toxin-A (Lipotoxin) Versus Normal Saline Instillation in Treatment of Patients With Refractory Overactive Bladder Syndrome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Hualien, Taiwán, 970
- Buddhist Tzu Chi General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults with age of 20 years old or above
- Patients with symptoms of urgency frequency and/or urge incontinence and a urgency severity scale (USS) of at least 2, with or without urodynamically proven detrusor overactivity (DO) (defined by the International Continence Society (ICS) recommendation as: spontaneous detrusor contraction occurring during bladder filling phase or occurring before uninhibited detrusor contraction voiding at bladder capacity in the urodynamic study)
- Free of active urinary tract infection
- Free of bladder outlet obstruction on enrollment
- Free of overt neurogenic bladder dysfunction
- Having been treated with antimuscarinic agents for at least 4 weeks without effect or with intolerable adverse effects
- Patient has not been treated with bladder surgery for OAB, such as enterocystoplasty, that might affect the therapeutic effect of test drug
- Patient can record voiding diary for the urinary frequency and urgency
- Patient or his/her legally acceptable representative has signed the written informed consent form
Exclusion Criteria:
- Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with bladder outlet obstruction on enrollment
- Patients with postvoid residual >150 mL
- Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
Patients have laboratory abnormalities at screening including:
Alanine aminotransferase (ALT) >3 x upper limit of normal range Aspartate aminotransferase (AST) >3 x upper limit of normal range Patients have abnormal serum creatinine level >2 x upper limit of normal range
- Patients with any contraindication to be urethral catheterization during treatment
- Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
- Myasthenia gravis, Eaton Lambert syndrome.
- Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial
- Patients participated investigational drug trial within 1 month before entering this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental arm
Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation Liposome encapsulated botulinum toxin A' |
Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day
Otros nombres:
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Comparador de placebos: Control arm
Normal saline 50 mL in single intravesical instillation Normal saline instillation' |
Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Change of the Total Frequency Per 3 Days
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy: Mean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary. Change = Week 4 minus Baseline value |
Baseline to 4 weeks after initial treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Change of the Urgency Episodes Per 3 Days
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy: Mean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary. Change = Week 4 minus Baseline value |
Baseline to 4 weeks after initial treatment
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Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy: Mean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary. Change = Week 4 minus Baseline value |
Baseline to 4 weeks after initial treatment
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Net Change of the Overactive Bladder Symptom Score (OABSS)
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively. The OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value |
Baseline to 4 weeks after initial treatment
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Net Change of the Functional Bladder Capacity (FBC)
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value
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Baseline to 4 weeks after initial treatment
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Net Change of the Maximum Flow Rate (Qmax)
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value
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Baseline to 4 weeks after initial treatment
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Net Change of the Postvoid Residual Volume (PVR)
Periodo de tiempo: Baseline and 1 month after initial treatment
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Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value
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Baseline and 1 month after initial treatment
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Net Change of the Urgency Severity Score (USS) Within 3 Days
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days.
The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.
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Baseline to 4 weeks after initial treatment
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Net Change of the Global Response Assessment (GRA)
Periodo de tiempo: Baseline to 4 weeks after initial treatment
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Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.
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Baseline to 4 weeks after initial treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yao-Chi Chuang, M.D., Department of Urology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urológicas
- Enfermedades de la vejiga urinaria
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Vejiga Urinaria Hiperactiva
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Agentes colinérgicos
- Moduladores de transporte de membrana
- Inhibidores de la liberación de acetilcolina
- Agentes neuromusculares
- Toxinas botulínicas
- Toxinas botulínicas, tipo A
- abobotulinumtoxinA
Otros números de identificación del estudio
- TCGHUROL001
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Ensayos clínicos sobre Liposome encapsulated botulinum toxin A
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