Clinical trial NCT01557244: A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Neurogenic
Keywords: neurogenic detrusor overactivity
neurogenic bladder
neuropathic bladder
neurologic disease
fesoterodine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 181
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase
timeFrame: Baseline up to Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase
timeFrame: Week 12 up to Week 26 (including 2 weeks of follow up after last dose)
measure: Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase
timeFrame: Baseline up to Week 12
measure: Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase
timeFrame: Week 1 up to Week 12
measure: Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase
timeFrame: Week 12 up to Week 26
measure: Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase
timeFrame: Week 1 up to Week 12
measure: Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase
timeFrame: Week 12 up to Week 26
measure: Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase
timeFrame: Baseline, Week 4, 12
measure: Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase
timeFrame: Baseline, Week 24
measure: Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase
timeFrame: Baseline up to Week 12
measure: Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase
timeFrame: Baseline up to Week 24
measure: Absorption Rate Constant (Ka) of Fesoterodine
timeFrame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)
measure: Apparent Oral Clearance (CL/F) of Fesoterodine
timeFrame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)
measure: Volume of Distribution (Vd) of Fesoterodine
timeFrame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: Orange
country: United States
facility: CHOC Children's Urology Center
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Georgia Urology, P.A.
state: Georgia
city: Atlanta
country: United States
facility: Judson L. Hawk Jr. M.D.
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Outpatient Center
state: Illinois
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Memorial Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Memorial Hospital Pediatric Clinic
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Liberty Township
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: East Providence
country: United States
facility: Advanced Radiology
state: Rhode Island
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Providence
country: United States
facility: University Urological Associates, Inc
state: Rhode Island
city: Providence
country: United States
facility: University Urological Associates, Inc.
state: Rhode Island
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Urologie
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
state: Bruxelles-capitale
city: Montreal
country: Canada
facility: Centre hospitalier universitaire (CHU) Sainte-Justine
state: Quebec
city: Tallinn
country: Estonia
facility: Tallinn Children's Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bron Cedex
country: France
facility: Centre d'Investigation Clinique
city: Bron Cedex
country: France
facility: Groupement Hospitalier Est - Hopital Femme Mere Enfant
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
state: Nordrhein-westfalen
city: Larissa
country: Greece
facility: University General Hospital of Larisa/ Urology Department
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
city: Ludhiana
country: India
facility: Department of Pediatrics, Christian Medical College and Hospital
state: Punjab
city: San Giovanni Rotondo
country: Italy
facility: I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche
state: Foggia
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù
city: Vicenza
country: Italy
facility: ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza
city: Obu
country: Japan
facility: Aichi Children's Health and Medical Center
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba Children's Hospital
state: Chiba, Japan
city: Fukuoka-shi
country: Japan
facility: Fukuoka Children's Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Hyogo prefectural Kobe Children's Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Children's Medical Center
state: Kanagawa
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Izumi-shi
country: Japan
facility: Osaka Medical Center and Research Institute for Maternal and Child Health
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Koshigaya Hospital
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Shizuoka Children's Hospital
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital / Urology
state: Tochigi
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital / Urology
state: Tokyo
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas klinikos
city: Vilnius
country: Lithuania
facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center
state: NCR
city: Gdansk
country: Poland
facility: Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy
city: Poznan
country: Poland
facility: Specjalistyczny Gabinet Lekarski Paweł Kroll
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Republic OF Tatarstan
city: Kazan
country: Russian Federation
facility: Children's Republican Clinical Hospital, Department of Pediatric Surgery
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical
city: Moscow
country: Russian Federation
facility: FGBNU Scientific center of children health
city: Moscow
country: Russian Federation
facility: SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO
city: Bratislava
country: Slovakia
facility: J. BREZA MEDICAL s.r.o.
city: Bratislava
country: Slovakia
facility: Narodny ustav detskych chorob
city: Cape Town
country: South Africa
facility: Red Cross Children's Hospital
state: Western CAPE
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesus
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Uppsala
country: Sweden
facility: Akademiska barnsjukhuset
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi
state: Konya / Turkey
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: