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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

This study is currently recruiting participants.
Verified September 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557244
First Posted: March 19, 2012
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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 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.

Condition Intervention Phase
Urinary Bladder, Neurogenic Drug: Fesoterodine PR 4 mg Drug: Fesoterodine PR 8 mg Drug: Oxybutynin Drug: Fesoterodine PR Drug: Fesoterodine BIC 2 mg Drug: Fesoterodine BIC 4 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum cystometric bladder capacity [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Detrusor pressure at maximum bladder capacity [ Time Frame: 12 weeks ]
  • Presence of involuntary detrusor contractions [ Time Frame: 12 weeks ]
  • Bladder volume at first involuntary detrusor contraction [ Time Frame: 12 weeks ]
  • Bladder compliance [ Time Frame: 12 weeks ]
  • Mean number of micturitions and/or catheterizations/day [ Time Frame: 12 weeks ]
  • Mean number of incontinence episodes/day [ Time Frame: 12 weeks ]
  • Mean urgency episodes/day if applicable [ Time Frame: 12 weeks ]
  • Mean volume voided per micturition or mean volume per catheterization [ Time Frame: 12 weeks ]

Estimated Enrollment: 192
Actual Study Start Date: July 2, 2012
Estimated Study Completion Date: November 14, 2019
Estimated Primary Completion Date: November 14, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine PR 4 mg
Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
Drug: Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 24 weeks
Experimental: 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.
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.
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.
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.
Other Name: Safety extension phase
Experimental: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.
Drug: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
Experimental: 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.
Drug: Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557244


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Hide Study Locations
Locations
United States, Arizona
Urological Associates of Southern Arizona Terminated
Tucson, Arizona, United States, 85715
United States, California
Childrens Hospital of Orange County Active, not recruiting
Orange, California, United States, 92868
CHOC Children's Urology Center Active, not recruiting
Orange, California, United States, 92868
United States, Georgia
Children's Healthcare of Atlanta Active, not recruiting
Atlanta, Georgia, United States, 30342
Georgia Urology, P.A. Active, not recruiting
Atlanta, Georgia, United States, 30342
Judson L. Hawk Jr. M.D. Active, not recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Loyola University Medical Center Active, not recruiting
Maywood, Illinois, United States, 60153
Loyola University Outpatient Center Active, not recruiting
Maywood, Illinois, United States, 60153
United States, Iowa
The Iowa Clinic Terminated
West Des Moines, Iowa, United States, 50266
United States, North Carolina
Investigational Drug Services, Department of Pharmacy Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Chapel Hill Memorial Hospital Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Memorial Hospital Pediatric Clinic Recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Cincinnati Children's Hospital Medical Center Recruiting
Liberty Township, Ohio, United States, 45044
United States, Rhode Island
Advanced Radiology (For Imaging Only) Terminated
East Providence, Rhode Island, United States, 02914
Pharma Resource Terminated
East Providence, Rhode Island, United States, 02915
University Urological Associates, Inc Terminated
Providence, Rhode Island, United States, 02904
University Urological Associates, Inc. Terminated
Providence, Rhode Island, United States, 02905
United States, Wisconsin
Children's Hospital of Wisconsin Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Belgium
Universitair Ziekenhuis Antwerpen, Urologie Recruiting
Edegem, Antwerpen, Belgium, 2650
Hôpital Universitaire des Enfants Reine Fabiola Recruiting
Bruxelles, Bruxelles-capitale, Belgium, 1020
Canada, Quebec
Centre hospitalier universitaire (CHU) Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Estonia
Tallinn Children's Hospital Recruiting
Tallinn, Estonia, 13419
Finland
Tampere University Hospital Active, not recruiting
Tampere, Finland, 33520
France
Centre d'Investigation Clinique Recruiting
Bron Cedex, France, 69677
Groupement Hospitalier Est - Hopital Femme Mere Enfant Recruiting
Bron Cedex, France, 69677
Hôpitaux Pédiatriques de Nice CHU-Lenval Recruiting
Nice, France, 06200
Hopital Robert Debre Recruiting
Paris, France, 75019
Hopital Robert Debre - Service Urologie Pédiatrique Recruiting
Paris, France, 75935
CHU de Reims American Memorial Hospital Recruiting
REIMS Cedex, France, 51092
Germany
Universitätsklinikum Bonn Recruiting
Bonn, Nordrhein-westfalen, Germany, 53113
Kliniken Maria Hilf GmbH Recruiting
Mönchengladbach, Nordrhein-westfalen, Germany, 41063
Greece
University General Hospital of Larisa/ Urology Department Recruiting
Larissa, Greece, 41110
Aristotle University of Thessaloniki, General Hospital Papageorgiou, 2nd Department of Urology Recruiting
Thessaloniki, Greece, 56429
India
Department of Pediatrics, Christian Medical College and Hospital Recruiting
Ludhiana, Punjab, India, 141 008
Italy
Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna- Active, not recruiting
Cagliari, Italy, 09134
Azienda Ospedaliera Universitaria Careggi Active, not recruiting
Firenze, Italy, 50139
IRCCS Ospedale Pediatrico Bambino Gesù Recruiting
Roma, Italy, 00165
I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza Active, not recruiting
Vicenza, Italy, 36100
Japan
Aichi Children`s Health and Medical Center Recruiting
Obu, Aichi, Japan, 474 8710
Chiba Children's Hospital Recruiting
Chiba-shi, Chiba, Japan, Japan, 266-0007
Fukuoka Children's Hospital Recruiting
Fukuoka-shi, Fukuoka, Japan, 813-0017
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Kanagawa Children's Medical Center Recruiting
Yokohama, Kanagawa, Japan, 232-8555
Shinshu University Hospital Active, not recruiting
Matsumoto, Nagano, Japan, 3908621
Osaka Medical Center and Research Institute for Maternal and Child Health Recruiting
Izumi-shi, Osaka, Japan, 594-1101
Dokkyo Medical University Koshigaya Hospital Active, not recruiting
Koshigaya, Saitama, Japan, 343-8555
Shizuoka Children's Hospital Recruiting
Shizuoka-shi, Shizuoka, Japan, 420 8660
Dokkyo Medical University Hospital / Urology Recruiting
Shimotsuga-gun, Tochigi, Japan, 321 0293
Jichi Medical University Hospital Active, not recruiting
Shimotsuke, Tochigi, Japan, 329 0498
The University of Tokyo Hospital / Urology Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan-si, Gyeongsangnam-do, Korea, Korea, Republic of, 50612
Korea University Guro Hospital Recruiting
Seoul, Korea, Korea, Republic of, 08308
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
ASAN Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 135-710
Malaysia
Hospital Selayang Recruiting
Batu Caves, Selangor, Malaysia, 68100
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
Philippines
Philippine Children's Medical Center Recruiting
Quezon City, Metro Manila, Philippines, 1100
Poland
Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy Active, not recruiting
Gdansk, Poland, 80-952
Specjalistyczny Gabinet Lekarski Paweł Kroll Terminated
Poznan, Poland, 61-512
Russian Federation
Kazan State Medical University Recruiting
Kazan, Republic of Tatarstan, Russian Federation, 420012
Children's Republican Clinical Hospital, Department of Pediatric Surgery Recruiting
Kazan, Russian Federation, 420138
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal Terminated
Moscow, Russian Federation, 105425
FGBNU Scientific center of children health Recruiting
Moscow, Russian Federation, 119991
SSS - Research Clinical Institute of Pediatrics GBOU VPO "RNRM university n.a. N.I. Pirogov" Recruiting
Moscow, Russian Federation, 125412
Slovakia
Detska Fakultna nemocnica s poliklinikou Bratislava Recruiting
Bratislava, Slovakia, 833 40
South Africa
Steve Biko Academic Hospital Recruiting
Pretoria, Gauteng, South Africa, 0084
Red Cross Children's Hospital Active, not recruiting
Cape Town, Western Cape, South Africa, 7700
Spain
Hospital Sant Joan de Deu Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Hospital Infantil Universitario Niño Jesus Recruiting
Madrid, Spain, 28009
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Regional Universitario Carlos Haya Active, not recruiting
Malaga, Spain, 29011
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Sweden
Akademiska barnsjukhuset Recruiting
Uppsala, Sweden, 751 85
Switzerland
Universitäts-Kinderspital beider Basel Active, not recruiting
Basel, Switzerland, 4031
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Recruiting
Konya, Konya / Turkey, Turkey, 42080
Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali Recruiting
Ankara, Sihhiye, Turkey, 06100
Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi Recruiting
Ankara, Turkey, 06100
Istanbul Universitesi Istanbul Tip Fakultesi Recruiting
Istanbul, Turkey, 34390
United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Alder Hey Children's Hospital Terminated
Liverpool, United Kingdom, L12 2AP
Royal Victoria Infirmary Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Sheffield Children's NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01557244     History of Changes
Other Study ID Numbers: A0221047
2010-022475-55 ( EudraCT Number )
First Submitted: March 15, 2012
First Posted: March 19, 2012
Last Update Posted: September 6, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Fesoterodine
Oxybutynin
Mandelic Acids
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents


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