A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
NCT ID: NCT01557244
Last Updated: 2021-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
181 participants
INTERVENTIONAL
2012-07-02
2020-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fesoterodine PR 4 mg
Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 24 weeks
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.
Fesoterodine PR 8 mg
Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
Fesoterodine PR 8 mg
Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
Oxybutynin
Oxybutynin
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.
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.
Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.
Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
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.
Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
Interventions
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Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 24 weeks
Fesoterodine PR 8 mg
Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
Fesoterodine PR 8 mg
Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
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.
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.
Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with stable neurological disease and neurogenic detrusor overactivity
* Subjects using clean intermittent catheterization may participate
Exclusion Criteria
* Other medical conditions which may increase the risk to subjects or confound study results
* Contraindications to the use of fesoterodine or oxybutynin
6 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Urological Associates of Southern Arizona
Tucson, Arizona, United States
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
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, , France
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, Germany
University General Hospital of Larisa/ Urology Department
Larissa, , Greece
Aristotle University of Thessaloniki
Thessaloniki, , Greece
Department of Pediatrics, Christian Medical College and Hospital
Ludhiana, Punjab, India
I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-
Cagliari, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, , Italy
ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza
Vicenza, , Italy
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
Chiba Children's Hospital
Chiba, Chiba, Japan, Japan
Fukuoka Children's Hospital
Fukuoka, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo prefectural Kobe Children's Hospital
Kobe, Hyōgo, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi-shi, Osaka, Japan
Dokkyo Medical University Koshigaya Hospital
Koshigaya, Saitama, Japan
Shizuoka Children's Hospital
Shizuoka, Shizuoka, Japan
Dokkyo Medical University Hospital / Urology
Shimotsuga-gun, Tochigi, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
The University of Tokyo Hospital / Urology
Bunkyo-ku, Tokyo, Japan
Hospital of Lithuanian University of Health Sciences Kaunas klinikos
Kaunas, , Lithuania
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Hospital Selayang
Batu Caves, Selangor, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Philippine Children's Medical Center
Quezon City, NCR, Philippines
Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy
Gdansk, , Poland
Specjalistyczny Gabinet Lekarski Paweł Kroll
Poznan, , Poland
FGBNU Scientific center of children health
Moscow, Russian Federation, Russia
Kazan State Medical University
Kazan', Tatarstan Republic, Russia
Children's Republican Clinical Hospital, Department of Pediatric Surgery
Kazan', , Russia
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical
Moscow, , Russia
SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO
Moscow, , Russia
J. BREZA MEDICAL s.r.o.
Bratislava, , Slovakia
Narodny ustav detskych chorob
Bratislava, , Slovakia
Red Cross Children's Hospital
Cape Town, Western Cape, South Africa
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Korea University Guro Hospital
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
ASAN Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Infantil Universitario Niño Jesus
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Akademiska barnsjukhuset
Uppsala, , Sweden
Universitäts-Kinderspital beider Basel
Basel, , Switzerland
National Cheng Kung University Hospital
Tainan City, , Taiwan
Necmettin Erbakan Universitesi Meram Tip Fakultesi
Konya, Konya / Turkey, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Leicester Royal Infirmary
Leicester, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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References
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Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.
Kitta T, Darekar A, Malhotra B, Shahin MH, Jones P, Lindsay M, Mallen S, Nieto A, Crook TJ. Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study. J Pediatr Urol. 2023 Apr;19(2):175.e1-175.e10. doi: 10.1016/j.jpurol.2022.11.020. Epub 2022 Nov 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-022475-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0221047
Identifier Type: -
Identifier Source: org_study_id
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