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. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557244
First received: March 15, 2012
Last updated: September 10, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detrusor pressure at maximum bladder capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Presence of involuntary detrusor contractions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bladder volume at first involuntary detrusor contraction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bladder compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Mean number of micturitions and/or catheterizations/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean number of incontinence episodes/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean urgency episodes/day if applicable [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean volume voided per micturition or mean volume per catheterization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 178
Study Start Date: July 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557244

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Arizona
Arizona Urologic Specialists Terminated
Tucson, Arizona, United States, 85712
Urological Associates of Southern Arizona Terminated
Tuscon, Arizona, United States, 85715
United States, California
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Children's Hospital of Orange County - Children's Urology Center Recruiting
Orange, California, United States, 92868
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
United States, Florida
Nemours Research Department (Regulatory Location) Recruiting
Orlando, Florida, United States, 32827
Nemours Children's Clinic Recruiting
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
United States, Georgia
Judson L. Hawk Jr. M.D. Recruiting
Atlanta, Georgia, United States, 30342
Georgia Urology, P.A. Recruiting
Atlanta, Georgia, United States, 30342
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Loyola University Outpatient Center, Recruiting
Maywood, Illinois, United States, 60153
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
United States, Iowa
The Iowa Clinic Completed
West Des Moines, Iowa, United States, 50266
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 Medicial Center Recruiting
Liberty Township, Ohio, United States, 45044
United States, Rhode Island
Pharma Resource Completed
East Providence, Rhode Island, United States, 02915
Advanced Radiology (For Imaging Only) Completed
East Providence, Rhode Island, United States, 02914
University Urological Associates, Inc. Completed
Providence, Rhode Island, United States, 02905
University Urological Associates, Inc Completed
Providence, Rhode Island, United States, 02904
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Belgium
UZ Antwerpen [Urology] Recruiting
Edegem, Belgium, 2650
Canada, Quebec
Centre hospitalier universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Estonia
Tallinn Children's Hospital Recruiting
Tallinn, Estonia, 13419
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33520
France
Groupe Hospitalier Est - Hopital Femme Mere Enfant Recruiting
Bron Cedex, France, 69677
Greece
University General Hospital of Larisa/ Urology Department Recruiting
Larisa, Greece, 41110
Aristotle University of Thessaloniki, Papageorgiou Hospital, 2nd Department of Urology Recruiting
Thessaloniki, Greece, 56403
India
Sterling Hospitals, Recruiting
Ahmedabad, Gujarat, India, 380 052
Christian Medical College Recruiting
Ludhiana, Punjab, India, 141 008
Italy
A.O. G. Brotzu Recruiting
Cagliari, Italy, 09134
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50139
Ospedale Bambino Gesu Recruiting
Fiumicino - Rome, Italy, 00050
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
Foggia, Italy, 71013
Ospedale Pediatrico Bambino Gesù - Centro Trial Recruiting
Roma, Italy, 00165
Ospedale Bambino Gesu Recruiting
Rome, Italy, 00165
Ospedale San Bortolo di Vicenza Unita Operativa Complessa di Chirurgia Pediatrica Recruiting
Vicenza, Italy, 36100
Japan
Aichi Children`s Health and Medical Center Recruiting
Morioka-cho, Obu, Aichi, Japan
Fukuoka Children's Hospital and Medical Center for Infectious Diseases Recruiting
Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital/Urology Recruiting
Sapporo, Hokkaido, Japan
Kanagawa Children's Medical Center Recruiting
Yokohama, Kanagawa, Japan
Shinshu University Hospital Recruiting
Matsumoto, Nagano, Japan
Dokkyo Medical University Koshigaya Hospital Completed
Koshigaya, Saitama, Japan
Jichi Medical University Hospital Recruiting
Shimotsuke, Tochigi, Japan
Dokkyo Medical University Hospital / Urology Recruiting
Tokyo, Tochigi, Japan
The University of Tokyo Hospital / Urology Completed
Bunkyo-ku, Tokyo, Japan
Chiba Children's Hospital Recruiting
Chiba, Japan
Shizuoka Children's Hospital Recruiting
Shizuoka, Japan
Korea, Republic of
ASAN Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Samsung Medical Center Completed
Seoul, Korea, Republic of, 135-710
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Malaysia
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CN
Poland
Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy Recruiting
Gdansk, Poland, 80-952
Gabinet Urologiczny Prof. Zbigniew Kwias Recruiting
Poznan, Poland, 61-664
Specjalistyczny Gabinet Lekarski Paweł Kroll Recruiting
Poznan, Poland, 61-512
Romania
Spitalul Clinic de Urgenta pentru copii "M.S Curie" Recruiting
Bucuresti, Romania, 041451
Russian Federation
FGBU "Scientific center of children health" of Russian Academy of Medical Sciences Recruiting
Moscow, Russian Federation, 119991
FGBU "Moscow Research Institute of Pediatrics and Pediatric Surgery" Recruiting
Moscow, Russian Federation, 125412
FGBU Scientific Research Institute of Urology of Ministry of Health of Russian Federation Recruiting
Moscow, Russian Federation, 105425
Slovakia
Detska Fakultna nemocnica s poliklinikou Bratislava Recruiting
Bratislava, Slovakia, 833 40
Martinska fakultna nemocnica, Urologicke oddelenie Recruiting
Martin, Slovakia, 036 59
MILAB s.r.o. Recruiting
Presov, Slovakia, 080 01
South Africa
Red Cross Children's Hospital Recruiting
Cape Town, Western Cape, South Africa, 7700
Spain
Hospital Sant Joan de Deu Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Infantil Universitario Niño Jesus Recruiting
Madrid, Spain, 28009
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Regional Universitario Carlos Haya Recruiting
Malaga, Spain, 29011
Sweden
Akademiska barnsjukhuset, Barnurologkliniken Recruiting
Uppsala, Sweden, 751 85
Switzerland
Universitäts-Kinderspital Recruiting
Basel, Switzerland, 4031
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Uroloji Anabilim Dali Recruiting
Istanbul, Capa, Turkey, 34390
Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi 4.Kat Uroloji Anabilim Dali Recruiting
Ankara, Turkey, 06100
Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali Recruiting
Ankara, Turkey, 06100
Konya Universitesi Meram Tip Fakultesi Hastanesi Recruiting
Konya, Turkey, 42080
United Kingdom
Sheffield Children's NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Alder Hey Children's Hospital Recruiting
Liverpool, United Kingdom, L12 2AP
Royal Manchester Children's Hospital Recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01557244     History of Changes
Other Study ID Numbers: A0221047
Study First Received: March 15, 2012
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014