EUCTR2010-022475-55-BE进行中（未招募）1 期
A 24-WEEK RANDOMIZED, OPEN-LABEL, ACTIVE COMPARATOR PERIOD FOLLOWED BY A 12-WEEK SAFETY EXTENSION PERIOD 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) - N/A
Pfizer Inc.235 East 42nd Street, New York, NY 100170 个研究点目标入组 186 人开始时间: 2013年10月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 186
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
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Male or female subjects aged 6 to 16 years 11 months (age at time of first dose); that is subjects who have passed their sixth birthday but not reached their seventeenth birthday.
- •2. Subjects with stable neurological disease and clinically- or urodynamically-demonstrated NDO, confirmed urodynamically at Visit 2, by detrusor overactivity or decreased bladder compliance, with decreased maximum cystometric bladder capacity.
- •NOTE: Subjects with hypocontractile bladder, detrusor underactivity, or a 'flaccid' bladder should not be included.
- •3. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative (or representatives, as per local regulatory and legal requirements) has been informed of all pertinent aspects of the study. In addition, an assent from the subject will be obtained when appropriate, and when the potential subject is capable of providing assent.
- •4. Female subjects who are of child-bearing potential (defined as =9 years old or have experienced menarche, whichever is earlier) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- •a. Subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization.
- •b. Subjects of child-bearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
- •c. Sexually active male subjects must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
- •5. Swallowing:
- •a. Subjects >25 kg must already have the ability to swallow tablets whole, without chewing or crushing. The first dose of medication will be given in clinic under observation, and any subject not able to swallow tablets will be excluded from the study.
- •b. Subjects =25 kg can either swallow the capsules whole or sprinkle on food.
- •6. Subjects, and their Caregivers/parents who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and othe study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 186
- •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
- •Subjects presenting with any of the following will not be included in the study:
- •(In France, see Appendix 5 of the protocol)
- •1. Any condition known to affect drug absorption (eg, gastrectomy).
- •2. History of surgical procedures that could confound study results or increase the risk to subjects, including but not limited to: sphincterotomy, artificial sphincter, implantable stent, bladder augmentation procedures, urinary diversion procedures. Continent diversion procedures eg, Mitrofanoff are permitted.
- •3. A history of indwelling urinary catheter within 4 weeks of participation in this study. Intermittent catheterization is permitted.
- •4. Any comorbid condition that, in the opinion of the investigator, would confound study results or increase the risk to subjects eg, current history of bladder calculus.
- •5. A history of autonomic dysreflexia eg, increased blood pressure with bladder filling or other stimuli.
- •6. Subjects with clinically relevant out-of-range values for hematology or serum chemistry as confirmed by blood tests performed at Visit 1, and which require the subject’s exclusion in the opinion of the investigator.
- •7. A 12-lead ECG at screening with clinically significant abnormality.
- •8. Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- •9. Subjects required to take or expected to initiate concomitant medications that can interact with the pharmacokinetics and/or pharmacodynamics of fesoterodine or oxybutynin, such as:
- •Potent CYP3A4 inhibitors within 3 weeks prior to Visit 2 (baseline), or the expectation to start such a treatment during the trial. • Medications capable of inducing CYP3A4 enzyme metabolism. • Drugs for the treatment of overactive bladder (eg, darifenacin, oxybutynin (including intravesical), propiverine, tolterodine, fesoterodine, solifenacin and trospium). • Treatment with botulinum toxin A within 9 months prior to Visit 2 (baseline). • Drugs with antispasmodic, parasympathetic, or cholinergic effects. Stable use of desmopressin for enuresis is allowed if established for at least 3 months.
- •Previous treatment with these medications does not exclude subjects. However, prohibited concomitant medications must have a minimum washout appropriate to the drug so any clinical effect is at a minimum prior to beginning the bladder diary, and baseline urodynamic evaluations.
- •10. Intermittent or unstable use of diuretics or alpha blockers, tricyclic antidepressants or any other treatment that may confound the results of the study, within 2 weeks or an appropriate washout period (whichever is longer) prior to starting the bladder diary or during the course of the study. Stable usage/dosage is allowed if established for at least 3 months.
- •11. Electrostimulation therapy or bladder retraining if started within 30 days of Visit 1 or are expected to start such therapy during the study period. Subjects who are on an established regimen may remain on this for the duration of the study.
- •12. Subjects with a clinically significant urinary tract infection (UTI) at screening.
- •Urine microscopy, culture and sensitivity testing will be performed in the event of:
- •presence of symptoms (eg, fever, fl
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