A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

PHASE3CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

July 2, 2012

Primary Completion Date

November 7, 2019

Study Completion Date

February 13, 2020

Conditions
Urinary Bladder, Neurogenic
Interventions
DRUG

Fesoterodine PR 4 mg

Fesoterodine 4 mg tablet once daily for 24 weeks

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.

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.

DRUG

Fesoterodine BIC 2 mg

Fesoterodine BIC 2 mg tablet once daily for 24 weeks.

DRUG

Fesoterodine BIC 4 mg

Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.

Trial Locations (84)

704

National Cheng Kung University Hospital, Tainan City

1020

Hôpital Universitaire des Enfants Reine Fabiola, Brussels

1100

Philippine Children's Medical Center, Quezon City

2650

Universitair Ziekenhuis Antwerpen, Urologie, Edegem

4031

Universitäts-Kinderspital beider Basel, Basel

7700

Red Cross Children's Hospital, Cape Town

13419

Tallinn Children's Hospital, Tallinn

27514

UNC Chapel Hill Memorial Hospital, Chapel Hill

UNC Memorial Hospital Pediatric Clinic, Chapel Hill

28007

Hospital General Universitario Gregorio Marañon, Madrid

28009

Hospital Infantil Universitario Niño Jesus, Madrid

29011

Hospital Regional Universitario Carlos Haya, Málaga

30342

Children's Healthcare of Atlanta, Atlanta

Georgia Urology, P.A., Atlanta

Judson L. Hawk Jr. M.D., Atlanta

33520

Tampere University Hospital, Tampere

34390

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

36100

ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza, Vicenza

41063

Kliniken Maria Hilf GmbH, Mönchengladbach

41110

University General Hospital of Larisa/ Urology Department, Larissa

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi, Konya

45044

Cincinnati Children's Hospital Medical Center, Liberty Township

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

50139

Azienda Ospedaliera Universitaria Careggi, Florence

50266

The Iowa Clinic, West Des Moines

50586

Hospital Kuala Lumpur, Kuala Lumpur

50612

Pusan National University Yangsan Hospital, Yangsan

53226

Children's Hospital of Wisconsin, Milwaukee

56429

Aristotle University of Thessaloniki, Thessaloniki

60153

Loyola University Medical Center, Maywood

Loyola University Outpatient Center, Maywood

68100

Hospital Selayang, Batu Caves

69677

Centre d'Investigation Clinique, Bron

Groupement Hospitalier Est - Hopital Femme Mere Enfant, Bron

71013

"I.R.C.C.S. - Ospedale Casa Sollievo della Sofferenza - Dipartimento Scienze Chirurgiche", San Giovanni Rotondo

85715

Urological Associates of Southern Arizona, Tucson

92868

Childrens Hospital of Orange County, Orange

CHOC Children's Urology Center, Orange

105425

Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical, Moscow

119991

FGBNU Scientific center of children health, Moscow

125412

SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO, Moscow

420012

Kazan State Medical University, Kazan'

420138

Children's Republican Clinical Hospital, Department of Pediatric Surgery, Kazan'

3908621

Shinshu University Hospital, Matsumoto

02914

Advanced Radiology, East Providence

02915

Pharma Resource, East Providence

02904

University Urological Associates, Inc, Providence

02905

University Urological Associates, Inc., Providence

H3T 1C5

Centre hospitalier universitaire (CHU) Sainte-Justine, Montreal

06200

Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice

141 008

Department of Pediatrics, Christian Medical College and Hospital, Ludhiana

09134

Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-, Cagliari

00165

IRCCS Ospedale Pediatrico Bambino Gesù, Roma

474 8710

Aichi Children's Health and Medical Center, Ōbu

266-0007

Chiba Children's Hospital, Chiba

813-0017

Fukuoka Children's Hospital, Fukuoka

060-8648

Hokkaido University Hospital, Sapporo

650-0047

Hyogo prefectural Kobe Children's Hospital, Kobe

232-8555

Kanagawa Children's Medical Center, Yokohama

594-1101

Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi-shi

343-8555

Dokkyo Medical University Koshigaya Hospital, Koshigaya

420 8660

Shizuoka Children's Hospital, Shizuoka

321 0293

Dokkyo Medical University Hospital / Urology, Shimotsuga-gun

329 0498

Jichi Medical University Hospital, Shimotsuke

113-8655

The University of Tokyo Hospital / Urology, Bunkyo-ku

LT-50161

Hospital of Lithuanian University of Health Sciences Kaunas klinikos, Kaunas

LT-08406

Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Vilnius

80-952

Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy, Gdansk

61-512

Specjalistyczny Gabinet Lekarski Paweł Kroll, Poznan

831 01

J. BREZA MEDICAL s.r.o., Bratislava

833 40

Narodny ustav detskych chorob, Bratislava

08308

Korea University Guro Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

ASAN Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

751 85

Akademiska barnsjukhuset, Uppsala

06100

Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi, Ankara

Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali, Ankara

LE1 5WW

Leicester Royal Infirmary, Leicester

L12 2AP

Alder Hey Children's Hospital, Liverpool

S10 2TH

Sheffield Children's NHS Foundation Trust, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY