A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
2 other identifiers
interventional
76
10 countries
21
Brief Summary
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2012
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedStudy Start
First participant enrolled
August 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2016
CompletedResults Posted
Study results publicly available
May 6, 2019
CompletedNovember 14, 2024
October 1, 2024
3.7 years
March 27, 2012
April 10, 2019
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
Baseline and Week 24
Secondary Outcomes (15)
Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
Baseline, Week 9 or Week 12
Change From Baseline in Bladder Compliance
Baseline and Week 24
Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
Baseline and Week 24
Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
Baseline and Week 24
Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
Baseline and Week 24
- +10 more secondary outcomes
Study Arms (1)
Solifenacin succinate
EXPERIMENTALParticipants aged 5 years to \< 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg. After completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52).
Interventions
Oral suspension administered once a day via syringe.
Eligibility Criteria
You may qualify if:
- Documented diagnosis of NDO, confirmed by urodynamics
- Practicing clean intermittent catheterization (CIC)
- Currently on treatment with an antimuscarinic drug
You may not qualify if:
- Known genitourinary condition (other than NDO) that may cause incontinence
- Bladder augmentation surgery
- Current Faecal impaction
- Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
- Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
- Reflux grade 3 or 4
- Current urinary tract infection (UTI)
- Subject has severe renal impairment (glomerular filtration rate \< 30 ml/min)
- Subject has severe hepatic impairment (Child-Pugh score \> 9).
- Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Site US1008
Tarrytown, New York, 10591, United States
Site US1010
Cincinnati, Ohio, 45229-3039, United States
Site BE3201
Ghent, 9000, Belgium
Site BR5505
São José do Rio Preto, São Paulo, 15090-000, Brazil
Site BR5507
Campinas, 13060-803, Brazil
Site BR5504
Campinas, 13083-887, Brazil
Site BR5506
Curitiba, 80240-060, Brazil
Site BR5503
Porto Alegre, 90035-903, Brazil
Site DK4501
Aarhus, 8200, Denmark
Site HU3602
Miskolc, 3526, Hungary
Site MX5203
León, 37000, Mexico
Site MX5205
Mexico City, C.P. 06700, Mexico
Site PH6301
Manila, 1015, Philippines
Site PH6302
Quezon City, 1101, Philippines
Site PL4803
Gdansk, 80-952, Poland
Site PL4805
Gdansk, 80803, Poland
Site PL4801
Warsaw, 04-730, Poland
Site KR8207
Seoul, 110744, South Korea
Site KR8201
Seoul, 120752, South Korea
Site TR9003
Ankara, 6100, Turkey (Türkiye)
Site TR9002
Izmir, 35100, Turkey (Türkiye)
Related Publications (2)
Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684.
PMID: 33231929DERIVEDFranco I, Hoebeke P, Baka-Ostrowska M, Bolong D, Davies LN, Dahler E, Snijder R, Stroosma O, Verheggen F, Newgreen D, Bosman B, Vande Walle J. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies. J Pediatr Urol. 2020 Apr;16(2):180.e1-180.e8. doi: 10.1016/j.jpurol.2019.12.012. Epub 2019 Dec 27.
PMID: 32007426DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
August 14, 2012
Primary Completion
April 28, 2016
Study Completion
April 28, 2016
Last Updated
November 14, 2024
Results First Posted
May 6, 2019
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.