A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics ofSolifenacin 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
- Other
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Change from baseline in maximum cystometric capacity (MCC)
研究概览
简要总结
The purpose of this study is to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents. 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 will be investigated. The take-up and length of time that the solifenacin suspension stays in the body will also be investigated during this study.
The study will last for approximately 12 months, where completing patients will receive 52 weeks of continuous treatment.
Effectiveness will be measured by urodynamics (the filling and emptying of the bladder) and urine volumes measured during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.
Safety assessments include analysis of the blood and urine, review of the ECG, ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
Study has been discontinued in India.
No Subjects were screened or enrolled for the study in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
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
- •Current urinary tract infection (UTI).
- •Subject has severe renal impairment (glomerular filtration rate less than 30 ml/min).
- •Subject has severe hepatic impairment (Child-Pugh score greater than 9).
- •Subject has received intra-vesical botulinum toxin within 9 months prior to screening.
结局指标
主要结局
Change from baseline in maximum cystometric capacity (MCC)
时间窗: Baseline and Week 24
次要结局
- Change in Maximum Cystometric Capacity (MCC)(Baseline, Week 9, Week 24 and Week 52)
- Change in Urodynamics(Measured by:)
- Change in Diary Observations(Measured by:)
- Change in Quality of Life(Baseline, Week 24 and Week 52)