A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 21
- 主要终点
- Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
研究概览
简要总结
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
详细描述
The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.
Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of NDO, confirmed by urodynamics
- •Practicing clean intermittent catheterization (CIC)
- •Currently on treatment with an antimuscarinic drug
排除标准
- •Known genitourinary condition (other than NDO) that may cause incontinence
- •Bladder augmentation surgery
- •Current Faecal impaction
- •Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
- •Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
- •Reflux grade 3 or 4
- •Current urinary tract infection (UTI)
- •Subject has severe renal impairment (glomerular filtration rate < 30 ml/min)
- •Subject has severe hepatic impairment (Child-Pugh score > 9).
- •Subject has received intra-vesical botulinum toxin within 9 months prior to screening
研究组 & 干预措施
Solifenacin succinate
Participants aged 5 years to < 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg.
After completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52).
干预措施: Solifenacin succinate (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
时间窗: Baseline and Week 24
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
次要结局
- Change From Baseline in Bladder Compliance(Baseline and Week 24)
- Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure(Baseline and Week 24)
- Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure(Baseline and Week 24)
- Change From Baseline in Average Catheterized Volume Per Catheterization(Baseline to Week 24)
- Change From Baseline in Maximum Catheterized Volume(Baseline to Week 24)
- Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days(Baseline to Week 24)
- Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)(Baseline to Week 24)
- Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity(Baseline, Week 9 or Week 12)
- Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling(Baseline to Week 24)
- Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours(Baseline to Week 24)
- Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)(Baseline and Week 24)
- Change From Baseline in Average First Morning Catheterized Volume(Baseline to Week 24)
- Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days(Baseline to Week 24)
- Change From Baseline in Detrusor Pressure at the End of Bladder Filling(Baseline to Week 24)
- Number of Participants With Adverse Events(Baseline to End of Study Visit (Week 52))