A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Completed · Phase 3
Conditions studied: Urinary Bladder, Neurogenic
In brief
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.
Key facts
- Study ID
- NCT01557244
- Run by
- Pfizer
- People needed
- 181
- Starts
- 2012-07-02
- Expected to finish
- 2020-02-13
- Last updated by the study team
- 2021-02-02
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects aged 6 to 17 years old
- Subjects with stable neurological disease and neurogenic detrusor overactivity
- Subjects using clean intermittent catheterization may participate
You may not qualify if…
- 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
Where it is running
- Childrens Hospital of Orange County — Orange, California, United States
- CHOC Children's Urology Center — Orange, California, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Georgia Urology, P.A. — Atlanta, Georgia, United States
- Judson L. Hawk Jr. M.D. — Atlanta, Georgia, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Loyola University Outpatient Center — Maywood, Illinois, United States
- The Iowa Clinic — West Des Moines, Iowa, United States
- UNC Chapel Hill Memorial Hospital — Chapel Hill, North Carolina, United States
- UNC Memorial Hospital Pediatric Clinic — Chapel Hill, North Carolina, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Cincinnati Children's Hospital Medical Center — Liberty Township, Ohio, United States
- Advanced Radiology — East Providence, Rhode Island, United States
- Pharma Resource — East Providence, Rhode Island, United States
- University Urological Associates, Inc — Providence, Rhode Island, United States
- University Urological Associates, Inc. — Providence, Rhode Island, United States
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
- Universitair Ziekenhuis Antwerpen, Urologie — Edegem, Antwerpen, Belgium
- Hôpital Universitaire des Enfants Reine Fabiola — Brussels, Brussels Capital, Belgium
- Centre hospitalier universitaire (CHU) Sainte-Justine — Montreal, Quebec, Canada
- Tallinn Children's Hospital — Tallinn, Estonia
- Tampere University Hospital — Tampere, Finland
- Centre d'Investigation Clinique — Bron, France
- Groupement Hospitalier Est - Hopital Femme Mere Enfant — Bron, France
- Urological Associates of Southern Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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