A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Average Catheterization Urine Volume
研究概览
简要总结
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
详细描述
This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
- •Use clean intermittent catheterization
- •On stable dose of oral oxybutynin before participation
排除标准
- •Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
- •Have any medical condition that precludes their participation in the study or may confound the outcome of the study
研究组 & 干预措施
Oxybutynin Transdermal System
Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
干预措施: Oxybutynin (Drug)
Oral oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
干预措施: Oxybutynin (Drug)
结局指标
主要结局
Average Catheterization Urine Volume
时间窗: 14 weeks
Change from baseline in average volume of urine collected by catheterization
次要结局
- Catheterizations Without Leakage(14 weeks)
- Urine Volume After First Awakening(14 weeks)