A Phase IIb/III, Multi-centre, Double-blind, Randomised, Placebo-controlled, Dose Ranging Study of Tamsulosin Hydrochloride (Low, Medium and High Dose) as Treatment in Children With Neuropathic Bladder for Three Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 231
- 主要终点
- Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.
研究概览
简要总结
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida)
- •Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements
排除标准
- •Clinically significant abnormalities as determined by the investigator
- •A history of relevant orthostatic hypotension, fainting spells or blackouts
研究组 & 干预措施
Placebo
Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks
干预措施: Placebo (Drug)
Low dose
Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
干预措施: tamsulosin hydrochloride (Drug)
Medium dose
Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
干预措施: tamsulosin hydrochloride (Drug)
High dose
Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
干预措施: tamsulosin hydrochloride (Drug)
结局指标
主要结局
Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.
时间窗: Week 14
The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.
次要结局
- Change From Baseline in LPP at Week 14 (End of Treatment)(Baseline and Week 14)
- Percentage Change From Baseline in LPP at Week 14 (End of Treatment)(Baseline and Week 14.)
- Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline(Baseline and Week 14)
- Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline(Baseline and Week 14)
- Change From Baseline in Urine Volume at Week 14(Baseline and Week 14)
- Change From Baseline in Number of Times Patient Was Wet at Catheterisation(Baseline and Week 14)
- Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.(From first drug administration until 28 days after last study drug administration, upto 160 days)
- Post Void Residual Volume at Week 14(Baseline and Week 14.)