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