Overview

Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.

Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its efficacy for overactive bladder syndrome in children.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stéphane Bolduc
Collaborator:
Pfizer
Treatments:
Fesoterodine
Criteria
Inclusion Criteria:

- Male or female ≥ 5 years old and ≤14 years old, and that completed the initial
randomized study (Foxy2014).

- OAB diagnostic according to the International Children Continence Society (ICCS) and
less than 65% of the expected mean bladder capacity for age is confirmed (30 + (age in
years x 30) mL) on a 3-day voiding diary.

- Weight and height are within the normal percentile (3rd to 97th percentile) and weight
is ≥ 20 kg (3rd percentile of a 8 y.o. child, boy or girl), according to the CDC
growth chart

- Ability to swallow pills

- Subjects/parents (vs. legal guardian) agree to participate to the following study and
sign the informed consent

- Subjects/parents (vs. legal guardian) are able to comply with the study requirements
and with the medication restrictions.

Female subjects of childbearing potential must have a negative serum or urine pregnancy
test at enrollment and must agree to maintain highly effective birth control during the
study. Sexually active male subjects agree to use a barrier method of birth control with
female partner for the duration of the study and at least one month after ending study
treatment. Sexually active male subjects agree to use a condom for the duration of the
study and for at least one month after ending study treatment and the female partner to use
a reliable form of birth control for the duration of the study and for at least one month
after ending study treatment.

Exclusion Criteria:

- Subject has a diagnostic of dysfunctional voiding

- Post-voiding residue > 20 cc

- Polyuria (> 75 ml/kg/b.w./24 hours)

- Nephrogenic of central diabetes insipidus

- Constipation at screening (if the patient is treated and the treatment is successful,
the patient will be eligible to the study)

- Urinary tract infection at visit 2-3-4. If UTI is present at the screening visit, the
UTI must be treated and the success of the treatment must be documented with a
negative urinalysis at visit 2.

- QTc interval greater than 460 ms, or any increase of 30 ms on follow-up EKG (mean of 6
separate EKG-3 from visit week-2 and 3 from visit week 0). If a patient meets those
criteria in the first month (initial dose), he will be excluded from the study. If the
QTc change is noted after the up-titration, the dose will be decreased and EKG will be
repeated within 1 week to ensure normalization of QTc.

- Clinically significant unstable medical condition or disorder

- Subject is pregnant or intends to become pregnant

- Serum creatinin more than or equal to 2 times the upper limit of normal

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal
to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN.

- Known hypersensitivity to Oxybutynin or Fesoterodine or any contraindication to the
use of those 2 molecules, in accordance to the product monography (to the exception of
pediatric age).

- Subject is taking medication that interact with Fesoterodine and this medication can't
be discontinued (see appendix 1 of excluded drugs)

- Known urological pathology other than OAB that could explain urinary symptoms (as
bladder stone…)

- Non-treated or non-controlled arterial hypertension