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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

Primary Purpose

Urinary Bladder, Neurogenic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fesoterodine PR 4 mg

Fesoterodine PR 8 mg

Oxybutynin

Fesoterodine PR

Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg

About this trial

This is an interventional treatment trial for Urinary Bladder, Neurogenic focused on measuring neurogenic detrusor overactivity, neurogenic bladder, neuropathic bladder, neurologic disease, fesoterodine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Urological Associates of Southern Arizona
Childrens Hospital of Orange County
CHOC Children's Urology Center
Children's Healthcare of Atlanta
Georgia Urology, P.A.
Judson L. Hawk Jr. M.D.
Loyola University Medical Center
Loyola University Outpatient Center
The Iowa Clinic
UNC Chapel Hill Memorial Hospital
UNC Memorial Hospital Pediatric Clinic
Cincinnati Children's Hospital Medical Center
Cincinnati Children's Hospital Medical Center
Advanced Radiology
Pharma Resource
University Urological Associates, Inc
University Urological Associates, Inc.
Children's Hospital of Wisconsin
Universitair Ziekenhuis Antwerpen, Urologie
Hôpital Universitaire des Enfants Reine Fabiola
Centre hospitalier universitaire (CHU) Sainte-Justine
Tallinn Children's Hospital
Tampere University Hospital
Centre d'Investigation Clinique
Groupement Hospitalier Est - Hopital Femme Mere Enfant
Hôpitaux Pédiatriques de Nice CHU-Lenval
Kliniken Maria Hilf GmbH
University General Hospital of Larisa/ Urology Department
Aristotle University of Thessaloniki
Department of Pediatrics, Christian Medical College and Hospital
I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche
Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-
Azienda Ospedaliera Universitaria Careggi
IRCCS Ospedale Pediatrico Bambino Gesù
ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza
Aichi Children's Health and Medical Center
Chiba Children's Hospital
Fukuoka Children's Hospital
Hokkaido University Hospital
Hyogo prefectural Kobe Children's Hospital
Kanagawa Children's Medical Center
Shinshu University Hospital
Osaka Medical Center and Research Institute for Maternal and Child Health
Dokkyo Medical University Koshigaya Hospital
Shizuoka Children's Hospital
Dokkyo Medical University Hospital / Urology
Jichi Medical University Hospital
The University of Tokyo Hospital / Urology
Pusan National University Yangsan Hospital
Korea University Guro Hospital
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
ASAN Medical Center
Samsung Medical Center
Hospital of Lithuanian University of Health Sciences Kaunas klinikos
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
Hospital Selayang
Hospital Kuala Lumpur
Philippine Children's Medical Center
Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy
Specjalistyczny Gabinet Lekarski Paweł Kroll
Kazan State Medical University
Children's Republican Clinical Hospital, Department of Pediatric Surgery
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical
FGBNU Scientific center of children health
SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO
J. BREZA MEDICAL s.r.o.
Narodny ustav detskych chorob
Red Cross Children's Hospital
Hospital Sant Joan de Deu
Hospital General Universitario Gregorio Marañon
Hospital Infantil Universitario Niño Jesus
Hospital Regional Universitario Carlos Haya
Hospital Universitari i Politecnic La Fe
Akademiska barnsjukhuset
Universitäts-Kinderspital beider Basel
National Cheng Kung University Hospital
Necmettin Erbakan Universitesi Meram Tip Fakultesi
Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi
Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali
Istanbul Universitesi Istanbul Tip Fakultesi
Leicester Royal Infirmary
Alder Hey Children's Hospital
Sheffield Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Fesoterodine PR 4 mg

Fesoterodine PR 8 mg

Oxybutynin

Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg

Arm Description

Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period

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.

Oxybutynin

Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase

Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O).

Secondary Outcome Measures

Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase

Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.

Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase

In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.

Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase

Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.

Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase

Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 micturitions at Baseline.

Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline.

Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline.

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with >0 urgency episodes at Baseline.

Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase

The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.

Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase

The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.

Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase

The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase

Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase

Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.

Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase

VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.

Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase

The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.

Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase

The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase

CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase

Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase

CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.

Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

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

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

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

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase

Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.

Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase

Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase

Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 colony forming unit per milliliter [CFU/mL]) and the presence of symptoms, or pyuria (defined as >50 white blood cells [WBC] per high-pass filter [hpf]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).

Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase

Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) and the presence of symptoms, or pyuria (defined as >50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.

Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase

Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.

Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase

Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase

Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.

Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase

Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase

Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.

Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase

Absorption Rate Constant (Ka) of Fesoterodine

Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Apparent Oral Clearance (CL/F) of Fesoterodine

Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Volume of Distribution (Vd) of Fesoterodine

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Full Information

NCT ID

NCT01557244

First Posted

March 15, 2012

Last Updated

January 12, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01557244

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

July 2, 2012 (Actual)

Primary Completion Date

November 7, 2019 (Actual)

Study Completion Date

February 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Neurogenic

Keywords

neurogenic detrusor overactivity, neurogenic bladder, neuropathic bladder, neurologic disease, fesoterodine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fesoterodine PR 4 mg

Arm Type

Experimental

Arm Description

Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period

Arm Title

Fesoterodine PR 8 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Oxybutynin

Arm Type

Active Comparator

Arm Description

Oxybutynin

Arm Title

Fesoterodine BIC 2 mg

Arm Type

Experimental

Arm Description

Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.

Arm Title

Fesoterodine BIC 4 mg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine PR 4 mg

Intervention Description

Fesoterodine 4 mg tablet once daily for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Fesoterodine PR 8 mg

Intervention Description

Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine PR 8 mg

Intervention Description

Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.

Intervention Type

Drug

Intervention Name(s)

Oxybutynin

Intervention Description

Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine PR

Other Intervention Name(s)

Safety extension phase

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine BIC 2 mg

Intervention Description

Fesoterodine BIC 2 mg tablet once daily for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine BIC 4 mg

Intervention Description

Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.

Primary Outcome Measure Information:

Title

Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase

Description

Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O).

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase

Description

Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.

Time Frame

Baseline, Week 12

Title

Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase

Description

Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase

Description

Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase

Description

The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase

Description

The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase

Description

Time Frame

Week 12 up to Week 26 (including 2 weeks of follow up after last dose)

Title

Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Time Frame

Baseline, Week 24

Title

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 24

Title

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 24

Title

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

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 24

Title

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

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase

Description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Time Frame

Baseline, Week 24

Title

Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase

Description

Time Frame

Baseline up to Week 24

Title

Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase

Description

Time Frame

Week 1 up to Week 12

Title

Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase

Description

Time Frame

Week 12 up to Week 26

Title

Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase

Description

Time Frame

Week 1 up to Week 12

Title

Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase

Description

Time Frame

Week 12 up to Week 26

Title

Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase

Description

Time Frame

Baseline, Week 4, 12

Title

Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase

Description

Time Frame

Baseline, Week 24

Title

Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase

Description

Time Frame

Baseline up to Week 24

Title

Absorption Rate Constant (Ka) of Fesoterodine

Description

Time Frame

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)

Title

Apparent Oral Clearance (CL/F) of Fesoterodine

Description

Time Frame

Title

Volume of Distribution (Vd) of Fesoterodine

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Urological Associates of Southern Arizona

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Childrens Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

CHOC Children's Urology Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Children's Healthcare of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Georgia Urology, P.A.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Judson L. Hawk Jr. M.D.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Loyola University Outpatient Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

The Iowa Clinic

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

UNC Chapel Hill Memorial Hospital

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

UNC Memorial Hospital Pediatric Clinic

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Liberty Township

State/Province

Ohio

ZIP/Postal Code

45044

Country

United States

Facility Name

Advanced Radiology

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Pharma Resource

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02915

Country

United States

Facility Name

University Urological Associates, Inc

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02904

Country

United States

Facility Name

University Urological Associates, Inc.

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

Facility Name

Children's Hospital of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Universitair Ziekenhuis Antwerpen, Urologie

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Hôpital Universitaire des Enfants Reine Fabiola

City

Bruxelles

State/Province

Bruxelles-capitale

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Centre hospitalier universitaire (CHU) Sainte-Justine

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Tallinn Children's Hospital

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Tampere University Hospital

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Centre d'Investigation Clinique

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Groupement Hospitalier Est - Hopital Femme Mere Enfant

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Hôpitaux Pédiatriques de Nice CHU-Lenval

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Name

Kliniken Maria Hilf GmbH

City

Mönchengladbach

State/Province

Nordrhein-westfalen

ZIP/Postal Code

41063

Country

Germany

Facility Name

University General Hospital of Larisa/ Urology Department

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Aristotle University of Thessaloniki

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Department of Pediatrics, Christian Medical College and Hospital

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141 008

Country

India

Facility Name

I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche

City

San Giovanni Rotondo

State/Province

Foggia

ZIP/Postal Code

71013

Country

Italy

Facility Name

Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-

City

Cagliari

ZIP/Postal Code

09134

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Careggi

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

IRCCS Ospedale Pediatrico Bambino Gesù

City

Roma

ZIP/Postal Code

00165

Country

Italy

Facility Name

ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza

City

Vicenza

ZIP/Postal Code

36100

Country

Italy

Facility Name

Aichi Children's Health and Medical Center

City

Obu

State/Province

Aichi

ZIP/Postal Code

474 8710

Country

Japan

Facility Name

Chiba Children's Hospital

City

Chiba-shi

State/Province

Chiba, Japan

ZIP/Postal Code

266-0007

Country

Japan

Facility Name

Fukuoka Children's Hospital

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

813-0017

Country

Japan

Facility Name

Hokkaido University Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Hyogo prefectural Kobe Children's Hospital

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Kanagawa Children's Medical Center

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

232-8555

Country

Japan

Facility Name

Shinshu University Hospital

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

3908621

Country

Japan

Facility Name

Osaka Medical Center and Research Institute for Maternal and Child Health

City

Izumi-shi

State/Province

Osaka

ZIP/Postal Code

594-1101

Country

Japan

Facility Name

Dokkyo Medical University Koshigaya Hospital

City

Koshigaya

State/Province

Saitama

ZIP/Postal Code

343-8555

Country

Japan

Facility Name

Shizuoka Children's Hospital

City

Shizuoka-shi

State/Province

Shizuoka

ZIP/Postal Code

420 8660

Country

Japan

Facility Name

Dokkyo Medical University Hospital / Urology

City

Shimotsuga-gun

State/Province

Tochigi

ZIP/Postal Code

321 0293

Country

Japan

Facility Name

Jichi Medical University Hospital

City

Shimotsuke

State/Province

Tochigi

ZIP/Postal Code

329 0498

Country

Japan

Facility Name

The University of Tokyo Hospital / Urology

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

Pusan National University Yangsan Hospital

City

Yangsan-si

State/Province

Gyeongsangnam-do

ZIP/Postal Code

50612

Country

Korea, Republic of

Facility Name

Korea University Guro Hospital

City

Seoul

State/Province

Korea

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

ASAN Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Hospital of Lithuanian University of Health Sciences Kaunas klinikos

City

Kaunas

ZIP/Postal Code

LT-50161

Country

Lithuania

Facility Name

Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

City

Vilnius

ZIP/Postal Code

LT-08406

Country

Lithuania

Facility Name

Hospital Selayang

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Hospital Kuala Lumpur

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Philippine Children's Medical Center

City

Quezon City

State/Province

NCR

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Specjalistyczny Gabinet Lekarski Paweł Kroll

City

Poznan

ZIP/Postal Code

61-512

Country

Poland

Facility Name

Kazan State Medical University

City

Kazan

State/Province

Republic OF Tatarstan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Children's Republican Clinical Hospital, Department of Pediatric Surgery

City

Kazan

ZIP/Postal Code

420138

Country

Russian Federation

Facility Name

Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical

City

Moscow

ZIP/Postal Code

105425

Country

Russian Federation

Facility Name

FGBNU Scientific center of children health

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO

City

Moscow

ZIP/Postal Code

125412

Country

Russian Federation

Facility Name

J. BREZA MEDICAL s.r.o.

City

Bratislava

ZIP/Postal Code

831 01

Country

Slovakia

Facility Name

Narodny ustav detskych chorob

City

Bratislava

ZIP/Postal Code

833 40

Country

Slovakia

Facility Name

Red Cross Children's Hospital

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Hospital Sant Joan de Deu

City

Esplugues de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Infantil Universitario Niño Jesus

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Regional Universitario Carlos Haya

City

Malaga

ZIP/Postal Code

29011

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Akademiska barnsjukhuset

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Universitäts-Kinderspital beider Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Necmettin Erbakan Universitesi Meram Tip Fakultesi

City

Konya

State/Province

Konya / Turkey

ZIP/Postal Code

42080

Country

Turkey

Facility Name

Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Istanbul Universitesi Istanbul Tip Fakultesi

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Leicester Royal Infirmary

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Alder Hey Children's Hospital

City

Liverpool

ZIP/Postal Code

L12 2AP

Country

United Kingdom

Facility Name

Sheffield Children's NHS Foundation Trust

City

Sheffield

ZIP/Postal Code

S10 2TH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221047&StudyName=A%20Study%20To%20Find%20Out%20How%20Fesoterodine%20Works%20In%20Children%20Aged%206%20To%2017%20Years%20With%20Bladder%20Overactivity%20Caused%20By%20A%20Neurological%20Condi

Description

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

Learn more about this trial

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

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