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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

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ClinicalTrials.gov Identifier: NCT01557244
Recruitment Status : Recruiting
First Posted : March 19, 2012
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : July 2, 2012
Estimated Primary Completion Date : November 13, 2019
Estimated Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Maximum cystometric bladder capacity [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Detrusor pressure at maximum bladder capacity [ Time Frame: 12 weeks ]
  2. Presence of involuntary detrusor contractions [ Time Frame: 12 weeks ]
  3. Bladder volume at first involuntary detrusor contraction [ Time Frame: 12 weeks ]
  4. Bladder compliance [ Time Frame: 12 weeks ]
  5. Mean number of micturitions and/or catheterizations/day [ Time Frame: 12 weeks ]
  6. Mean number of incontinence episodes/day [ Time Frame: 12 weeks ]
  7. Mean urgency episodes/day if applicable [ Time Frame: 12 weeks ]
  8. Mean volume voided per micturition or mean volume per catheterization [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557244


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 95 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01557244     History of Changes
Other Study ID Numbers: A0221047
2010-022475-55 ( EudraCT Number )
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Fesoterodine
Oxybutynin
Mandelic Acids
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents