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

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:

Drug Information available for: Oxybutynin chloride Oxybutynin Fesoterodine Fesoterodine fumarate

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

Hide Study Locations

Locations

United States, Arizona
Arizona Urologic Specialists	Recruiting
Tucson, Arizona, United States, 85712
Urological Associates of Southern Arizona	Recruiting
Tuscon, Arizona, United States, 85715
United States, California
Kaiser Permanente Los Angeles Medical Center	Recruiting
Los Angeles, California, United States, 90027
Children's Hospital of Orange County - Children's Urology Center	Not yet recruiting
Orange, California, United States, 92868
Children's Hospital of Orange County	Not yet recruiting
Orange, California, United States, 92868
United States, Connecticut
Connecticut Children's Medical Center	Not yet recruiting
Hartford, Connecticut, United States, 06106
United States, Georgia
Children's Healthcare of Atlanta	Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
United States, Iowa
The Iowa Clinic	Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kentucky
University of Kentucky	Not yet recruiting
Lexington, Kentucky, United States, 40536
United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
United States, Ohio
Akron Children's Hospital	Not yet recruiting
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center - Division of Pediatric Urology	Not yet recruiting
Cincinnati, Ohio, United States, 45229
United States, Rhode Island
Advanced Radiology (For Imaging Only)	Active, not recruiting
East Providence, Rhode Island, United States, 02914
Pharma Resource	Active, not recruiting
East Providence, Rhode Island, United States, 02915
University Urological Associates, Inc	Active, not recruiting
Providence, Rhode Island, United States, 02904
University Urological Associates, Inc.	Active, not recruiting
Providence, Rhode Island, United States, 02905
United States, Wisconsin
Children's Hospital of Wisconsin	Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Centre hospitalier universitaire Sainte-Justine	Not yet recruiting
Montreal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Sherbrooke	Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Estonia
Tallinn Children's Hospital	Recruiting
Tallinn, Estonia, 13419
Finland
Tampere University Hospital	Recruiting
Tampere, Finland, 33520
Italy
A.O. G. Brotzu	Not yet recruiting
Cagliari, Italy, 09134
Azienda Ospedaliera Universitaria Careggi	Not yet recruiting
Firenze, Italy, 50139
Japan
Aichi Children`s Health and Medical Center	Recruiting
Morioka-cho, Obu, Aichi, Japan
Hokkaido University Hospital/Urology	Recruiting
Sapporo, Hokkaido, Japan
Kanagawa Children's Medical Center	Recruiting
Yokohama, Kanagawa, Japan
Shinshu University Hospital	Recruiting
Matsumoto, Nagano, Japan
Dokkyo Medical University Koshigaya Hospital	Recruiting
Koshigaya, Saitama, Japan
Jichi Medical University Hospital	Recruiting
Shimotsuke, Tochigi, Japan
Dokkyo Medical University Hospital / Urology	Active, not recruiting
Tokyo, Tochigi, Japan
The University of Tokyo Hospital / Urology	Recruiting
Bunkyo-ku, Tokyo, Japan
Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
ASAN Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Severance Hospital	Recruiting
Seoul, Korea, Republic of, 120-752
Malaysia
Hospital Kuala Lumpur	Not yet recruiting
Kuala Lumpur, Malaysia, 50586
Slovakia
Detska Fakultna nemocnica s poliklinikou Bratislava	Recruiting
Bratislava, Slovakia, 833 40
Spain
Hospital Sant Joan de Deu	Not yet recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Universitario 12 de Octubre	Not yet recruiting
Madrid, Spain, 28041
Sweden
Akademiska barnsjukhuset, Barnurologkliniken	Recruiting
Uppsala, Sweden, 751 85

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 16, 2013