NCT01557244已完成3 期
A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 181
- 试验地点
- 83
- 主要终点
- Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
研究概览
简要总结
The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the 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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 6 to 17 years old
- •Subjects with stable neurological disease and neurogenic detrusor overactivity
- •Subjects using clean intermittent catheterization may participate
排除标准
- •Concomitant medications which may increase the risk to subjects or confound study results
- •Other medical conditions which may increase the risk to subjects or confound study results
- •Contraindications to the use of fesoterodine or oxybutynin
研究组 & 干预措施
Fesoterodine PR 4 mg
Experimental
Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
干预措施: Fesoterodine PR 4 mg (Drug)
Fesoterodine PR 8 mg
Experimental
Fesoterodine 8 mg for first week followed by 11 weeks at 8 mg in active control period, followed by 12 weeks in safety extension period.
干预措施: Fesoterodine PR 8 mg (Drug)
Oxybutynin
Active Comparator
Oxybutynin
干预措施: Oxybutynin (Drug)
Oxybutynin
Active Comparator
Oxybutynin
干预措施: Fesoterodine PR (Drug)
Fesoterodine BIC 2 mg
Experimental
Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.
干预措施: Fesoterodine BIC 2 mg (Drug)
Fesoterodine BIC 4 mg
Experimental
Fesoterodine BIC 4 mg for first week followed by 11 weeks at 8 mg in the efficacy period, followed by 12 weeks in safety extension period.
干预措施: Fesoterodine BIC 4 mg (Drug)
结局指标
主要结局
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
时间窗: Baseline, Week 12
Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of \>=40 centimeter (cm) water (H2O).
次要结局
- Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase(Baseline up to Week 12)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase(Week 12 up to Week 26 (including 2 weeks of follow up after last dose))
- Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Apparent Oral Clearance (CL/F) of Fesoterodine(Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic))
- Volume of Distribution (Vd) of Fesoterodine(Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic))
- Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase(Baseline up to Week 12)
- Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase(Baseline up to Week 24)
- Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase(Week 12 up to Week 26)
- Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase(Baseline up to Week 12)
- Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase(Baseline, Week 24)
- Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase(Week 12 up to Week 26)
- Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 4, 12)
- Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase(Week 1 up to Week 12)
- Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase(Baseline, Week 24)
- Absorption Rate Constant (Ka) of Fesoterodine(Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic))
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase(Baseline, Week 24)
- Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase(Baseline, Week 12)
- Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase(Week 1 up to Week 12)
- Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase(Baseline up to Week 24)
研究者
研究点 (83)
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