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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Bladder, Neurogenic

Intervention: Fesoterodine PR 4 mg (Drug); Fesoterodine PR 8 mg (Drug); Fesoterodine PR 8 mg (Drug); Oxybutynin (Drug); Fesoterodine PR (Drug); Fesoterodine BIC 2 mg (Drug); Fesoterodine BIC 4 mg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum cystometric bladder capacity

Secondary outcome:

Detrusor pressure at maximum bladder capacity

Presence of involuntary detrusor contractions

Bladder volume at first involuntary detrusor contraction

Bladder compliance

Mean number of micturitions and/or catheterizations/day

Mean number of incontinence episodes/day

Mean urgency episodes/day if applicable

Mean volume voided per micturition or mean volume per catheterization

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

UZ Antwerpen [Urology], Edegem 2650, Belgium; Recruiting

Tallinn Children's Hospital, Tallinn 13419, Estonia; Recruiting

Tampere University Hospital, Tampere 33520, Finland; Recruiting

Centre d'Investigation Clinique, Bron Cedex 69677, France; Recruiting

Groupement Hospitalier Est, BRON Cedex 69677, France; Recruiting

Groupement Hospitalier Est - Hopital Femme Mere Enfant, Bron Cedex 69677, France; Recruiting

University General Hospital of Larisa/ Urology Department, Larisa 41110, Greece; Recruiting

Aristotle University of Thessaloniki, Papageorgiou Hospital, 2nd Department of Urology, Thessaloniki 56429, Greece; Recruiting

A.O. G. Brotzu, Cagliari 09134, Italy; Active, not recruiting

Azienda Ospedaliera Universitaria Careggi, Firenze 50139, Italy; Active, not recruiting

IRCCS Ospedale Casa Sollievo della Sofferenza, Foggia 71013, Italy; Recruiting

IRCCS Ospedale Pediatrico Bambino Gesù, Rome 00165, Italy; Recruiting

ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza, Vicenza 36100, Italy; Active, not recruiting

Chiba Children's Hospital, Chiba 266-0007, Japan; Recruiting

ASAN Medical Center, Seoul 138-736, Korea, Republic of; Active, not recruiting

Samsung Medical Center, Seoul 135-710, Korea, Republic of; Active, not recruiting

Severance Hospital, Yonsei University Health System, Seoul 120-752, Korea, Republic of; Active, not recruiting

Hospital Kuala Lumpur, Kuala Lumpur 50586, Malaysia; Active, not recruiting

Clinstile, S.A. de C.V., Mexico City 06700, Mexico; Recruiting

Erasmus MC, Rotterdam 3015 CN, Netherlands; Recruiting

Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy, Gdansk 80-952, Poland; Active, not recruiting

Specjalistyczny Gabinet Lekarski Paweł Kroll, Poznan 61-512, Poland; Active, not recruiting

Institute of Urology Hertsen FMRCMHRF, Moscow 105425, Russian Federation; Recruiting

Research Clinical Institute of Pediatrics, Moscow 125412, Russian Federation; Recruiting

Scientific Children's Health Center, Moscow 119991, Russian Federation; Recruiting

Detska Fakultna nemocnica s poliklinikou Bratislava, Bratislava 833 40, Slovakia; Recruiting

Hospital Infantil Universitario Niño Jesus, Madrid 28009, Spain; Not yet recruiting

Hospital Universitario 12 de Octubre, Madrid 28041, Spain; Not yet recruiting

Hospital Regional Universitario Carlos Haya, Malaga 29011, Spain; Active, not recruiting

Akademiska barnsjukhuset, Barnurologkliniken, Uppsala 751 85, Sweden; Active, not recruiting

Universitäts-Kinderspital beider Basel, Basel CH-4031, Switzerland; Active, not recruiting

National Cheng Kung University Hospital, Tainan 704, Taiwan; Active, not recruiting

Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi 4.Kat Uroloji Anabilim Dali, Ankara 06100, Turkey; Recruiting

Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali, Ankara 06100, Turkey; Recruiting

Konya Universitesi Meram Tip Fakultesi Hastanesi, Konya 42080, Turkey; Recruiting

Leicester Royal Infirmary, Leicester LE1 5WW, United Kingdom; Recruiting

Alder Hey Children's Hospital, Liverpool L12 2AP, United Kingdom; Recruiting

Royal Manchester Children's Hospital, Manchester M13 9WL, United Kingdom; Recruiting

Aichi Children`s Health and Medical Center, Morioka-cho, Obu, Aichi, JAPAN 474-8710, Japan; Recruiting

Urological Associates of Southern Arizona, Tuscon, Arizona 85715, United States; Terminated

Hospital Sant Joan de Deu, Esplugues de Llobregat, Barcelona 08950, Spain; Recruiting

Children's Hospital of Orange County - Children's Urology Center, Orange, California 92868, United States; Active, not recruiting

Childrens Hospital of Orange County, Orange, California 92868, United States; Active, not recruiting

Istanbul Universitesi Istanbul Tip Fakultesi Uroloji Anabilim Dali, Istanbul, Capa 34390, Turkey; Recruiting

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting

Nemours Children's Clinic, Orlando, Florida 32806, United States; Recruiting

Nemours Children's Hospital, Orlando, Florida 32827, United States; Recruiting

Nemours Research Department ( Regulatory Location ), Orlando, Florida 32827, United States; Recruiting

Fukuoka Children's Hospital, Fukuoka-shi, Fukuoka 813-0017, Japan; Recruiting

Children's Healthcare of Atlanta, Atlanta, Georgia 30342, United States; Recruiting

Georgia Urology, P.A., Atlanta, Georgia 30342, United States; Recruiting

Judson L. Hawk Jr. M.D., Atlanta, Georgia 30342, United States; Recruiting

Hokkaido University Hospital, Sapporo, Hokkaido 060-8648, Japan; Recruiting

Loyola University Medical Center, Maywood, Illinois 60153, United States; Recruiting

Loyola University Outpatient Center, Maywood, Illinois 60153, United States; Recruiting

The Iowa Clinic, West Des Moines, Iowa 50266, United States; Active, not recruiting

Kanagawa Children's Medical Center, Yokohama, Kanagawa 232-8555, Japan; Recruiting

Hospital General Universitario Gregorio Marañon, Madrid, Madrid, Spain 28007, Spain; Recruiting

Shinshu University Hospital, Matsumoto, Nagano 3908621, Japan; Active, not recruiting

Akron Children's Hospital, Akron, Ohio 44308, United States; Recruiting

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting

Cincinnati Children's Hospital Medical Center, Liberty Township, Ohio 45044, United States; Recruiting

Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi-shi, Osaka 594-1101, Japan; Recruiting

Department of Pediatrics, Christian Medical College and Hospital, Ludhiana, Punjab 141 008, India; Recruiting

Centre hospitalier universitaire Sainte-Justine, Montreal, Quebec H3T 1C5, Canada; Recruiting

Advanced Radiology (For Imaging Only), East Providence, Rhode Island 02914, United States; Active, not recruiting

Pharma Resource, East Providence, Rhode Island 02915, United States; Active, not recruiting

University Urological Associates, Inc, Providence, Rhode Island 02904, United States; Active, not recruiting

University Urological Associates, Inc., Providence, Rhode Island 02905, United States; Active, not recruiting

Dokkyo Medical University Koshigaya Hospital, Koshigaya, Saitama 343-8555, Japan; Active, not recruiting

Shizuoka Children's Hospital, Aoi-ku, Shizuoka-shi, Shizuoka 420 8660, Japan; Recruiting

Sheffield Children's NHS Foundation Trust, Sheffield, South Yorkshire S10 2TH, United Kingdom; Recruiting

Jichi Medical University Hospital, Shimotsuke, Tochigi 329-0498, Japan; Recruiting

Dokkyo Medical University Hospital / Urology, Tokyo, Tochigi 321-0293, Japan; Recruiting

The University of Tokyo Hospital / Urology, Bunkyo-ku, Tokyo 113-8655, Japan; Active, not recruiting

Red Cross Children's Hospital, Cape Town, Western Cape 7700, South Africa; Active, not recruiting

Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2012
Last updated: August 20, 2015

Page last updated: August 23, 2015

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