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 May 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557244
First received: March 15, 2012
Last updated: May 12, 2016
Last verified: May 2016
  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: 187
Study Start Date: July 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: January 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

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
Urological Associates of Southern Arizona Terminated
Tucson, Arizona, United States, 85715
United States, California
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868
CHOC 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, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Georgia Urology, P.A. Recruiting
Atlanta, Georgia, United States, 30342
Judson L. Hawk Jr. M.D. Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
United States, Iowa
The Iowa Clinic Recruiting
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 Medical Center Recruiting
Liberty Township, Ohio, United States, 45044
United States, Rhode Island
Advanced Radiology (For Imaging Only) Recruiting
East Providence, Rhode Island, United States, 02914
Pharma Resource Recruiting
East Providence, Rhode Island, United States, 02915
University Urological Associates, Inc. Recruiting
Providence, Rhode Island, United States, 02905
University Urological Associates, Inc Recruiting
Providence, Rhode Island, United States, 02904
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Belgium
Universitair Ziekenhuis Antwerpen, Urologie Recruiting
Edegem, Belgium, 2650
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 Recruiting
Tampere, Finland, 33520
France
Groupement Hospitalier Est Recruiting
BRON Cedex, France, 69677
Centre d'Investigation Clinique Recruiting
Bron Cedex, France, 69677
Groupement Hospitalier Est - Hopital Femme Mere Enfant Recruiting
Bron Cedex, France, 69677
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 Terminated
Ludhiana, Punjab, India, 141 008
Italy
Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna- Recruiting
Cagliari, Italy, 09134
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50139
IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo- Recruiting
Foggia, Italy, 71013
IRCCS Ospedale Pediatrico Bambino Gesù Recruiting
Roma, Italy, 00165
ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza Recruiting
Vicenza, Italy, 36100
Japan
Aichi Children`s Health and Medical Center Recruiting
Obu, Aichi, Japan, 474-8710
Chiba Children's Hospital Recruiting
Midori-ku Chiba-shi, Chiba, 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 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 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 Recruiting
Shimotsuke, Tochigi, Japan, 329-0498
The University of Tokyo Hospital / Urology Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
ASAN Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Malaysia
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
Poland
Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy Recruiting
Gdansk, Poland, 80-952
Specjalistyczny Gabinet Lekarski Paweł Kroll Recruiting
Poznan, Poland, 61-512
Russian Federation
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal Recruiting
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
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 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 Recruiting
Malaga, Spain, 29011
Sweden
Akademiska barnsjukhuset Recruiting
Uppsala, Sweden, 751 85
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, Turkey, 06100
Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi 4.Kat Recruiting
Ankara, Turkey, 06100
Istanbul Universitesi Istanbul Tip Fakultesi Uroloji Anabilim Dali Recruiting
Istanbul, Turkey, 34390
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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01557244     History of Changes
Other Study ID Numbers: A0221047  2010-022475-55 
Study First Received: March 15, 2012
Last Updated: May 12, 2016
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
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Fesoterodine
Oxybutynin
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on May 30, 2016