A 8 Weeks, Randomized, Open Label, Parallel Group, Active Control Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline to weeke 8 in maximum volume voided (MVV) per 48 hours for age group 5 to 18 years
研究概览
简要总结
The purpose of this study was to assess the efficacy of Hibero (Mirabegron) versus active control (Ditropan: Oxybutynin Chloride) in the treatment of pediatric subjects (5 to < 18 years of age) with overactive bladder. This study will further evaluate the safety of mirabegron in pediatric subjects with OAB after multiple dose adminstration.
详细描述
The trial consists of four periods (Screening/ Washout (2 weeks); Baseline; 4 weeks from baseline; 8 weeks from baseline) excluding the safety monitoring period. It is a randomized, open label, parallel group, and active control comparator trial. The subject will be assigned either to Hibero (Mirabegron) 50 mg or Ditropan (Oxybutynin Chloride) 10 mg at baseline (randomization). The subject will be asked to take the IP or active comparator by mouth without crushing the pill for 8 weeks, and the frequency of oral administration depends on the prescribed method.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with overactive bladder (incontinence, frequent urination, enuresis) according to the International Children's Continence Society (ICCS)
- •Ages between 5 and 18
- •Subject has baseline body weight of 11 kg
- •Subject has symptoms of overactive bladder even after two weeks of wash-out period
- •Subject is able to follow and record information on 48 hours voiding diary during the trial period
- •Subject is able to swallow oral pill form of Hibero (Mirabegron) or Ditropan (Oxybutynin Chloride)
- •Subject has agreed to be followed up for 10 weeks, including the safety monitoring period
- •Subject, who is sexually active, has agreed to use at least one effective contraceptive method throughout the trial period, including the safety monitoring period.
- •The baseline hCG urine test should be negative for female subject to be enrolled in the trial.
- •Subject has normal ECG and vital signs (blood pressure, pulse) at the time of screening
排除标准
- •Subject has been diagnosed with congenital lower urinary tract dysfunction, neurogenic detrusor overactivity, or secondary detrusor overactivity.
- •Subject is currently in treatment for psychiatric disorder (i.e. depression, attention-deficit/ hyperactivity disorder, bipolar disorder, schizophrenia)
- •Subject uses clean intermittent catheterization (CIC) for neurogenic detrusor overactivity or due to urologic dysfunction.
- •At the time of baseline (randomization), the urine test returns positive for urinary tract infection (UTI).
- •Subject has a history of operation on the lower urinary tract or due to vesicoureteral reflux.
- •Subject is unable to swallow the pill form of Hibero (Mirabegron) or Ditropan (Oxybutynin Chloride).
- •Subject is unwilling or unable to follow the directions from the clinical trial team.
- •Subject has been exposed to either mirabegron or any form of antimuscarinic before the study enrollment (as for antimuscarinic, a subject may be enrolled after two weeks of washout period).
- •Subject has anaphylactic reactions either to mirabegron or ditropan
- •Subject has moderate to severe hepatic or renal impairment subjects.
- •Subject has been prescribed with strong CYP3A4 inhibitors and have moderate-severe hepatic or renal impairment
- •Subject with the following conditions: lower urinary tract obstruction, urinary retention, glaucoma, narrow tunnel vision, paralytic intestinal obstruction, moderate-severe cardiovascular impaired, ulcerative colitis
- •As both investigational products contain lactose, the administration of the products is prohibited for those with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Subject with uncontrolled hypertension, which is defined as systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg.
- •Subject has previous history or currently in treatment for any type of cardiovascular disorders.
研究组 & 干预措施
Hibero SR (Mirabegron) 50 mg
Subjects aged between 5 and 18 years will receive a daily dose of IP orally starting from baseline to week 8.
干预措施: Mirabegron 50 MG (Drug)
Ditropan (Oxybutynin Chloride) 10 mg
Subjects aged between 5 and 18 years will receive a daily dose of active comparator orally starting from baseline to week 8.
干预措施: Oxybutynin Chloride 5 MG (Drug)
结局指标
主要结局
Change from baseline to weeke 8 in maximum volume voided (MVV) per 48 hours for age group 5 to 18 years
时间窗: Baseline, Week 4, Week 8
Subject will complete 2-days voiding diary (48 hours) before each visit. Maximum voided volume will be derived from the 2-day voiding diary.
次要结局
- Total frequency of urinary urgency(Baseline, Week 4, Week 8)
- Dysfunctional Voiding Symptoms Score, DVSS(Baseline, Week 4, Week 8)
- Investigational Product (IP) Adherence and Accountability(Week 4, Week 8)
- Total frequency of urinary incontinence(Baseline, Week 4, Week 8)
研究者
Kwanjin Park
Professor
Seoul National University Hospital