Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.

NCT02614482 | Completed Phase 3 DMC

• 1 other identifier: 2016-2574
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its efficacy for overactive bladder syndrome in children.

Conditions

Overactive Bladder

Keywords

Children; Antimuscarinics; Antocholinergics; Overactive bladder

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Fesoterodine.

  Side effects: the number of patients presenting side effects of grade 1, 2 and 3 (mild, moderate, severe). Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment will be aggregated to arrive at one reported value. Between study arms, for cardiovascular safety: mean difference in blood pressure, mean difference in heart rate, mean difference in QTcB. * Vital signs (blood pressure and heart rate), * Increase of more than 20% of heart rate at rest * Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg * Or symptoms suggesting it, without reaching those variations. o Parameters to be measure at each visit, to be obtained before and 1 hour after taking the medication. Blood tests profile comparing number of subjects with significant changes: Blood work (including hepatic and renal workups, electrolytes, Hb-Ht).

  12 months

Secondary Outcomes (4)

• Number of Participants with Improved Overactive Bladder Symptoms as a Measure of Efficacy of Fesoterodine

  12 months

• Number of urinary incontinence episodes as a Measure of Efficacy of Fesoterodine

  12 months

• Number of urgency incontinence episodes as a Measure of Efficacy of Fesoterodine

  12 months

• Improvement in quality of life

  12 months

Study Arms (1)

Fesoterodine 4mg

EXPERIMENTAL

Fesoterodine 4 mg Po Die, dose could be increased to 8mg Po Die after 1 month and 4 months.

Drug: Fesoterodine

Interventions

Fesoterodine DRUG

Administer medication to patients with overactive bladder

Also known as: Toviaz

Fesoterodine 4mg

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stéphane Bolduc: lead
• Pfizer: collaborator

Study Sites (1)

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephane Bolduc, MD

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: November 25, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after publication
• Access Criteria: online via journal

Locations

CA (1)