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

Last updated on August 15, 2018

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Study Location
Urological Associates of Southern Arizona
Tucson, Arizona, 85715 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neurogenic Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01557244
Pfizer
Recruiting
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

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A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Bladder, Neurogenic
  • 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.
    Other Name: Safety extension phase
  • 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.
  • Experimental: Fesoterodine PR 4 mg
    Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
    Intervention: Drug: Fesoterodine PR 4 mg
  • Experimental: Fesoterodine PR 8 mg
    Fesoterodine 8 mg for first week followed by 11 weeks at 8 mg in active control period, followed by 12 weeks in safety extension period.
    Interventions:
    • Drug: Fesoterodine PR 8 mg
    • Drug: Fesoterodine PR 8 mg
  • Active Comparator: Oxybutynin
    Oxybutynin
    Interventions:
    • Drug: Oxybutynin
    • Drug: Fesoterodine PR
  • Experimental: Fesoterodine BIC 2 mg
    Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.
    Intervention: Drug: Fesoterodine BIC 2 mg
  • Experimental: Fesoterodine BIC 4 mg
    Fesoterodine BIC 4 mg for first week followed by 11 weeks at 8 mg in the efficacy period, followed by 12 weeks in safety extension period.
    Intervention: Drug: Fesoterodine BIC 4 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
192
November 13, 2019
November 13, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium,   Canada,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Mexico,   Netherlands,   Romania
 
NCT01557244
A0221047
2010-022475-55 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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