MedTrace Logo

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

NCT01557244 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2021-02-02

Study results available
· View outcomes & findings →

Summary

The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.

Conditions

  • Urinary Bladder, Neurogenic

Interventions

DRUG

Fesoterodine PR 4 mg

Fesoterodine 4 mg tablet once daily for 24 weeks

DRUG

Fesoterodine PR 8 mg

Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.

DRUG

Fesoterodine PR 8 mg

Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.

DRUG

Oxybutynin

Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.

DRUG

Fesoterodine PR

Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.

DRUG

Fesoterodine BIC 2 mg

Fesoterodine BIC 2 mg tablet once daily for 24 weeks.

DRUG

Fesoterodine BIC 4 mg

Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-02
Primary Completion
2019-11-07
Completion
2020-02-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Japan
  • Lithuania
  • Malaysia
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557244 on ClinicalTrials.gov