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Gottlieb Memorial Hospital

MacNeal Hospital

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NCT01557244

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

Official Title:

A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)

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.

Eligibility

Inclusion Criteria:

* Subjects aged 6 to 17 years old
* Subjects with stable neurological disease and neurogenic detrusor overactivity
* Subjects using clean intermittent catheterization may participate

Exclusion Criteria:

* Concomitant medications which may increase the risk to subjects or confound study results
* Other medical conditions which may increase the risk to subjects or confound study results
* Contraindications to the use of fesoterodine or oxybutynin

Disease(s) and\or Condition(s)

Urinary Bladder, Neurogenic

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Fesoterodine PR 4 mg
    • Description: Fesoterodine 4 mg tablet once daily for 24 weeks
    • Arm Group Labels: Fesoterodine PR 4 mg
    • Type: DRUG
    • Name: Fesoterodine PR 8 mg
    • Description: Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
    • Arm Group Labels: Fesoterodine PR 8 mg
    • Type: DRUG
    • Name: Fesoterodine PR 8 mg
    • Description: Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
    • Arm Group Labels: Fesoterodine PR 8 mg
    • Type: DRUG
    • Name: Oxybutynin
    • Description: Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.
    • Arm Group Labels: Oxybutynin
    • Type: DRUG
    • Name: Fesoterodine PR
    • Description: 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.
    • Arm Group Labels: Oxybutynin
    • Type: DRUG
    • Name: Fesoterodine BIC 2 mg
    • Description: Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
    • Arm Group Labels: Fesoterodine BIC 2 mg
    • Type: DRUG
    • Name: Fesoterodine BIC 4 mg
    • Description: Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
    • Arm Group Labels: Fesoterodine BIC 4 mg
Sponsor
  • Pfizer