EUCTR2014-004161-24-Outside-EU/EEA进行中（未招募）不适用
An Open-Label, Dose-Escalating Study of the Pharmacokinetics, Safety and Tolerability of Fesoterodine in Pediatric Overactive Bladder Patients Aged 8-17 Years
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 个研究点目标入组 21 人开始时间: 2015年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female subjects between the ages of 8 and 17 years (age at time of first dose), inclusive.
- •2.A total body weight greater than 25 kilogram (kg) or 55 pounds (lbs).
- •3.Symptoms of urinary frequency (greater than or equal to [=] 8 micturitions on average per 24 hours) and urgency (defined as a sudden and compelling desire to pass urine which is difficult to defer), with or without urgency incontinence, for at least 6 months prior to enrolment or subjects with stable neurological disease and urodynamically confirmed detrusor over activity, who may require intermittent catheterization for management of urinary drainage.
- •4.Parents or legal guardians must give written informed consent prior to the start of the study. Consent should be obtained from both (if available) of the child’s legal representatives (parents or guardians). In addition, the child’s assent must be obtained.
- •5.Female subjects must be non-pregnant and non-lactating, and, if applicable, be using an appropriate method of contraception for at least 28 days prior to the first dose of study medication and continue for at least 28 days after the final study drug dose. Subjects of child bearing potential must have confirmed negative urine pregnancy tests taken prior to randomization.
- •6.Subjects and parents or legal guardians must be thought to be compliant and able to follow the investigator’s instructions. They must be able to visit the clinic on schedule and be both cooperative and reliable.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects required to take concomitant medications that could have interacted with the pharmacokinetics (PK) and pharmacodynamics (PD) of fesoterodine, such as Cytochrome CYP3A4 inhibitors or inducers, CYP2D6 inhibitors, drugs for treatment of OAB, drugs with antispasmodic, parasympathetic, or cholinergic effects, drugs known to affect lower urinary tract function (eg, desmopressin).
- •2.Subjects who had received any electro stimulation therapy or bladder retraining within 4 weeks of Visit 1 or who were expected to start such therapy during the study period.
- •3.Subjects with monosymptomatic nocturnal enuresis, or giggle incontinence.
- •4.Subjects with a clinically significant urinary tract infection at screening.
- •5.Subjects with a relevant disease with which their urinary symptoms may have been associated like diabetes insipidus, untreated constipation, psychological disorders with impact on bladder function.
- •6.Subjects with any condition that would have contraindicated or warranted precautions for the use of fesoterodine, including: hypersensitivity to fesoterodine or tolterodine, history of hypersensitivity to peanut or soya, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis and toxic megacolon.
研究者
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