A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 10
- 主要终点
- Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6
研究概览
简要总结
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
详细描述
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
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
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 years to < 17 years
- •Neurogenic bladder
- •Neurological condition
排除标准
- •Have anatomical bladder abnormalities
- •Sensitivity to anticholinergics
- •Bladder augmentation
研究组 & 干预措施
DB: OTG (Pre-Amend 3)
Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks.
Followed by OL OTG for 8 weeks.
干预措施: Oxybutynin (Drug)
OL: OTG (Post-Amend 3)
Open-Label Oxybutynin Chloride topical gel (OTG) (Pre & Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks.
干预措施: Oxybutynin (Drug)
DB: Placebo (Pre-Amend 3)
Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6
时间窗: Baseline (Week 0) up to Week 6
The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.
次要结局
- Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6(Baseline (Week 0) up to week 6)
- Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6(Baseline (Week 0) up to Week 6)
- Change From Baseline in Average Number of Catheterizations Per Day at Week 6(Baseline (Week 0) up to Week 6)