A clinical research study to find out how the medicine fesoterodine works in children aged 6 to 17 years with bladder overactivity caused by a neurological condition (such as spina bifida).

Phase 1

Conditions: eurogenic Detrusor Overactivity (NDO).
MedDRA version: 17.0Level: PTClassification code 10029279Term: Neurogenic bladderSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2010-022475-55-NL

Lead Sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 181

Inclusion Criteria

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 17 years 11 months (age at time of first dose); that is subjects who have passed their sixth birthday but not reached their eighteenth 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 other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 118
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

Exclusion Criteria

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, flank pain), or • positive leucocytes and/or nitrites on urinalysis, or • if subject has a documented history of vesicoureteral reflux (VUR).
A clinically significant UTI is defined as:
• positive urine culture with a uropathogen and the presence of symptoms, or • pyuria (defined as >

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method