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. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557244
First received: March 15, 2012
Last updated: July 15, 2014
Last verified: July 2014
  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 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.


Condition Intervention Phase
Urinary Bladder, Neurogenic
Drug: Fesoterodine PR 4 mg
Drug: Fesoterodine PR 8 mg
Drug: Oxybutynin
Drug: Fesoterodine PR
Drug: Fesoterodine BIC 2 mg
Drug: Fesoterodine BIC 4 mg
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 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)

Resource links provided by NLM:


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: 178
Study Start Date: July 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine PR 4 mg
Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
Drug: Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 24 weeks
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.
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.
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.
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
Experimental: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.
Drug: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
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.
Drug: Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557244

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

  Show 79 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: July 15, 2014
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
Fesoterodine
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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014