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

NCT01557244 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: A02210472010-022475-55
• Study Type: interventional
• Target: 181
• Locations: 24 countries
• Sites: 83

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.

Conditions

Urinary Bladder, Neurogenic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Week 12

Secondary Outcomes (47)

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

  Baseline, Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

Study Arms (5)

Fesoterodine PR 4 mg

EXPERIMENTAL

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 PR 8 mg

EXPERIMENTAL

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

Oxybutynin

ACTIVE COMPARATOR

Oxybutynin

Drug: Oxybutynin; Drug: Fesoterodine PR

Fesoterodine BIC 2 mg

EXPERIMENTAL

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 4 mg

EXPERIMENTAL

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

Interventions

Fesoterodine PR 4 mg DRUG

Fesoterodine 4 mg tablet once daily for 24 weeks

Fesoterodine PR 4 mg

Fesoterodine PR 8 mg DRUG

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

Fesoterodine PR 8 mg

Oxybutynin DRUG

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

Oxybutynin

Fesoterodine PR DRUG

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.

Also known as: Safety extension phase

Oxybutynin

Fesoterodine BIC 2 mg DRUG

Fesoterodine BIC 2 mg tablet once daily for 24 weeks.

Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg DRUG

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

Fesoterodine BIC 4 mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects aged 6 to 17 years old
• Subjects with stable neurological disease and neurogenic detrusor overactivity
• Subjects using clean intermittent catheterization may participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (84)

Urological Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

Childrens Hospital of Orange County

Orange, California, 92868, United States

Location

CHOC Children's Urology Center

Orange, California, 92868, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Georgia Urology, P.A.

Atlanta, Georgia, 30342, United States

Location

Judson L. Hawk Jr. M.D.

Atlanta, Georgia, 30342, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Loyola University Outpatient Center

Maywood, Illinois, 60153, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

UNC Chapel Hill Memorial Hospital

Chapel Hill, North Carolina, 27514, United States

Location

UNC Memorial Hospital Pediatric Clinic

Chapel Hill, North Carolina, 27514, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Cincinnati Children's Hospital Medical Center

Liberty Township, Ohio, 45044, United States

Location

Advanced Radiology

East Providence, Rhode Island, 02914, United States

Location

Pharma Resource

East Providence, Rhode Island, 02915, United States

Location

University Urological Associates, Inc

Providence, Rhode Island, 02904, United States

Location

University Urological Associates, Inc.

Providence, Rhode Island, 02905, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universitair Ziekenhuis Antwerpen, Urologie

Edegem, Antwerpen, 2650, Belgium

Location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Brussels Capital, 1020, Belgium

Location

Centre hospitalier universitaire (CHU) Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Tallinn Children's Hospital

Tallinn, 13419, Estonia

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Centre d'Investigation Clinique

Bron, 69677, France

Location

Groupement Hospitalier Est - Hopital Femme Mere Enfant

Bron, 69677, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, 06200, France

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, North Rhine-Westphalia, 41063, Germany

Location

University General Hospital of Larisa/ Urology Department

Larissa, 41110, Greece

Location

Aristotle University of Thessaloniki

Thessaloniki, 56429, Greece

Location

Department of Pediatrics, Christian Medical College and Hospital

Ludhiana, Punjab, 141 008, India

Location

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

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-

Cagliari, 09134, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50139, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

Location

ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza

Vicenza, 36100, Italy

Location

Aichi Children's Health and Medical Center

Ōbu, Aichi-ken, 474 8710, Japan

Location

Chiba Children's Hospital

Chiba, Chiba, Japan, 266-0007, Japan

Location

Fukuoka Children's Hospital

Fukuoka, Fukuoka, 813-0017, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Hyogo prefectural Kobe Children's Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Kanagawa Children's Medical Center

Yokohama, Kanagawa, 232-8555, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, 3908621, Japan

Location

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi-shi, Osaka, 594-1101, Japan

Location

Dokkyo Medical University Koshigaya Hospital

Koshigaya, Saitama, 343-8555, Japan

Location

Shizuoka Children's Hospital

Shizuoka, Shizuoka, 420 8660, Japan

Location

Dokkyo Medical University Hospital / Urology

Shimotsuga-gun, Tochigi, 321 0293, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329 0498, Japan

Location

The University of Tokyo Hospital / Urology

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Hospital of Lithuanian University of Health Sciences Kaunas klinikos

Kaunas, LT-50161, Lithuania

Location

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

Vilnius, LT-08406, Lithuania

Location

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Philippine Children's Medical Center

Quezon City, NCR, 1100, Philippines

Location

Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy

Gdansk, 80-952, Poland

Location

Specjalistyczny Gabinet Lekarski Paweł Kroll

Poznan, 61-512, Poland

Location

FGBNU Scientific center of children health

Moscow, Russian Federation, 119991, Russia

Location

Kazan State Medical University

Kazan', Tatarstan Republic, 420012, Russia

Location

Children's Republican Clinical Hospital, Department of Pediatric Surgery

Kazan', 420138, Russia

Location

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

Moscow, 105425, Russia

Location

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

Moscow, 125412, Russia

Location

J. BREZA MEDICAL s.r.o.

Bratislava, 831 01, Slovakia

Location

Narodny ustav detskych chorob

Bratislava, 833 40, Slovakia

Location

Red Cross Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Korea University Guro Hospital

Seoul, Korea, 08308, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

ASAN Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Niño Jesus

Madrid, 28009, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29011, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Akademiska barnsjukhuset

Uppsala, 751 85, Sweden

Location

Universitäts-Kinderspital beider Basel

Basel, 4031, Switzerland

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Necmettin Erbakan Universitesi Meram Tip Fakultesi

Konya, Konya / Turkey, 42080, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, 34390, Turkey (Türkiye)

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, L12 2AP, United Kingdom

Location

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

Related Publications (2)

• Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.

  PMID: 36892754 DERIVED

• Kitta T, Darekar A, Malhotra B, Shahin MH, Jones P, Lindsay M, Mallen S, Nieto A, Crook TJ. Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study. J Pediatr Urol. 2023 Apr;19(2):175.e1-175.e10. doi: 10.1016/j.jpurol.2022.11.020. Epub 2022 Nov 29.

  PMID: 36504158 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 19, 2012
• Study Start: July 2, 2012
• Primary Completion: November 7, 2019
• Study Completion: February 13, 2020
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (4); BE (2); PL (2); JP (13); ES (5); MY (2); RU (5); SL (2); PH (1); CH (1); LI (2); GR (2); GB (3); FR (3); CA (1); DE (1); FI (1); TW (1); IN (1); US (18); ZA (1); IT (5); KR (6); SE (1)