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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

This study is currently recruiting participants.
Verified October 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557244
First Posted: March 19, 2012
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
March 15, 2012
March 19, 2012
October 4, 2017
July 2, 2012
November 14, 2019   (Final data collection date for primary outcome measure)
Maximum cystometric bladder capacity [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01557244 on ClinicalTrials.gov Archive Site
  • Detrusor pressure at maximum bladder capacity [ Time Frame: 12 weeks ]
  • Presence of involuntary detrusor contractions [ Time Frame: 12 weeks ]
  • Bladder volume at first involuntary detrusor contraction [ Time Frame: 12 weeks ]
  • Bladder compliance [ Time Frame: 12 weeks ]
  • Mean number of micturitions and/or catheterizations/day [ Time Frame: 12 weeks ]
  • Mean number of incontinence episodes/day [ Time Frame: 12 weeks ]
  • Mean urgency episodes/day if applicable [ Time Frame: 12 weeks ]
  • Mean volume voided per micturition or mean volume per catheterization [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
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 14, 2019
November 14, 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 ClinicalTrials.gov_Inquiries@pfizer.com
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
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP