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A Study To Find Out How Fesoterodine Works In Children Aged 6 To 16 Years With Bladder Overactivity Caused By A Neurological Condition

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557244
First received: March 15, 2012
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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 16 years old and weigh more than 25 kg (55 lb). 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.


Condition Intervention Phase
Urinary Bladder, Neurogenic
 Drug: Fesoterodine 4 mg
Drug: Fesoterodine 8 mg
Drug: Oxybutynin
Drug: Fesoterodine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Week Randomized, Open-Label, Active Comparator Period Followed By A 12-Week Safety Extension Period To Evaluate The Safety And Efficacy Of Fesoterodine In Subjects Aged 6 To 16 Years And >25 Kg With Symptoms Of Detrusor Overactivity Associated With A Neurological Condition (Neurogenic Detrusor Overactivity)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum cystometric bladder capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detrusor pressure at maximum bladder capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Presence of involuntary detrusor contractions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bladder volume at first involuntary detrusor contraction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bladder compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Mean number of micturitions and/or catheterizations/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean number of incontinence episodes/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean urgency episodes/day if applicable [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean volume voided per micturition or mean volume per catheterization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine 4 mg
Fesoterodine 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
 Drug: Fesoterodine 4 mg
Fesoterodine 4 mg tablet once daily for 12 weeks
Other Name: Active comparator phase
Experimental: Fesoterodine 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.
 Drug: Fesoterodine 8 mg
Fesoterodine 8 mg tablet once daily for 12 weeks
Other Name: Active comparator phase
Active Comparator: Oxybutynin
Oxybutynin
 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.
Other Name: Active comparator arm
Drug: Fesoterodine
Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks. Those assigned to 8 mg will take 4 mg for the first week.
Other Name: Safety extension phase

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged 6 to 16 years old and weighing more than 25 kg
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557244

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 40 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01557244     History of Changes
Other Study ID Numbers: A0221047
Study First Received: March 15, 2012
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neurogenic detrusor overactivity
neurogenic bladder
neuropathic bladder
neurologic disease
fesoterodine

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Oxybutynin
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013