Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children

NCT02327936 | Completed Phase 3 DMC

• 1 other identifier: FOXY2014
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL and to compare their efficacy for overactive bladder syndrome in children.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

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

  Side effects: the number of patients in each arm presenting side effects of grade 1, 2 and 3 (mild, moderate, severe). 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 but particularly at visit 2 (Week 0, first dose on site), 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).

  4 months

Secondary Outcomes (2)

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

  4 months

• Number of urgency and urinary incontinence episodes as a Measure of Efficacy of Fesoterodine and Oxybutynin XL

  4 months

Study Arms (2)

Fesoterodine 4mg

EXPERIMENTAL

Fesoterodine 4 mg Po Die, dose could be increased to 8mg Po Die after 4 weeks, for a total of 8 weeks

Drug: Fesoterodine

Oxybutynin XL 10mg

ACTIVE COMPARATOR

Oxybutynin XL 10 mg Po Die, dose could be increased to 20 mg Po Die after 4 weeks, for a total of 8 weeks

Drug: Oxybutynin XL

Interventions

Fesoterodine DRUG

Administer medication to patients with overactive bladder

Also known as: Toviaz

Fesoterodine 4mg

Oxybutynin XL DRUG

Administer medication to patients with overactive bladder

Also known as: Ditropan XL

Oxybutynin XL 10mg

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
• 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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine; Tolterodine Tartrate

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

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Stéphane Bolduc, MD

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: March 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