A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
LION
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
2 other identifiers
interventional
189
15 countries
44
Brief Summary
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2014
CompletedResults Posted
Study results publicly available
January 30, 2017
CompletedOctober 31, 2024
October 1, 2024
1.6 years
March 27, 2012
December 5, 2016
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.
Baseline and Week 12
Secondary Outcomes (19)
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
Baseline and Week 12
- +14 more secondary outcomes
Study Arms (4)
Placebo Children
PLACEBO COMPARATORChildren aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
Solifenacin Succinate Suspension Children
EXPERIMENTALChildren aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Placebo Adolescents
PLACEBO COMPARATORAdolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
Solifenacin Succinate Suspension Adolescents
PLACEBO COMPARATORAdolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Interventions
Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
Children aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
Non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB.
Eligibility Criteria
You may qualify if:
- Written Informed Consent has been obtained
- OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
- Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary
You may not qualify if:
- Daily voiding frequency less than 5
- Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
- Uroflow indicative of pathology other than OAB
- Maximum voided volume (morning volume excluded) \> expected bladder capacity for age \[(age +1) x 30\] in ml or a maximum voided volume (morning volume excluded) above 390 ml
- Post Void Residual (PVR) \> 20 ml
- Monosymptomatic enuresis
- Polyuria defined as \> 75 ml/kg/b.w./24 hours
- Dysfunctional voiding
- Congenital anomalies affecting lower urinary tract function
- Current constipation
- Current Urinary Tract Infection (UTI)
- Catheterization within 2 weeks prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Site: 1006
Shreveport, Louisiana, 71106, United States
Site: 1015
Albany, New York, 12208, United States
Site: 3202
Antwerp, 2020, Belgium
Site: 3209
Antwerp, 2650, Belgium
Site: 3208
Charleroi, 6000, Belgium
Site: 3201
Ghent, 9000, Belgium
Site: 3203
Ghent, 9000, Belgium
Site: 3204
Kortrijk, 8500, Belgium
Site: 3205
Leuven, 3000, Belgium
Site: 5507
Campinas, 13087-567, Brazil
Site: 5506
Curitiba, 80240-060, Brazil
Site: 1005
Hamilton, L8N 3Z5, Canada
Site: 1001
Québec, G1V 4G2, Canada
Site: 4503
Aalborg, DK-9000, Denmark
Site: 4501
Aarhus N, 8200, Denmark
Site: 4502
Kolding, 6000, Denmark
Site: 4504
Køge, 4600, Denmark
Site: 5202
Mexico City, 4530, Mexico
Site: 5205
Mexico City, C.P.06700, Mexico
Site: 4701
Bergen, 5021, Norway
Site: 4702
Trondheim, 7030, Norway
Site: 6301
Quezon City, 1108, Philippines
Site: 4805
Gdansk, 80-803, Poland
Site: 4803
Gdansk, 80-952, Poland
Site: 4804
Lubin, 20-093, Poland
Site: 4801
Warsaw, 04-736, Poland
Site: 3810
Belgrade, 11 000, Serbia and Montenegro
Site: 3812
Novi Sad, 21000, Serbia and Montenegro
Site: 2703
Cape Town, 7700, South Africa
Site:8203
Daegu, 705717, South Korea
Site: 8206
Incheon, 400-711, South Korea
Site: 8207
Seoul, 110744, South Korea
Site: 8201
Seoul, 120752, South Korea
Site:8202
Seoul, 156707, South Korea
Site: 4606
Gothenburg, 41685, Sweden
Site: 4601
Jönköping, 55185, Sweden
Site: 4603
Skövde, 54185, Sweden
Site: 4602
Stockholm, 11883, Sweden
Site: 4605
Umeå, 90185, Sweden
Site: 9001
Ankara, 6100, Turkey (Türkiye)
Site: 9002
Izmir, 35100, Turkey (Türkiye)
Site: 3853
Dnipropetrovsk, 49100, Ukraine
Site: 3854
Kharkiv, Ukraine
Site: 3850
Kiev, 1103, Ukraine
Site: 4403
Leeds, LS1 3EX, United Kingdom
Site: 4401
Sheffield, S10 2TH, United Kingdom
Related Publications (3)
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: 33231929DERIVEDSnijder R, Bosman B, Stroosma O, Agema M. Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial. Eur J Pediatr. 2020 Oct;179(10):1523-1528. doi: 10.1007/s00431-020-03635-2. Epub 2020 Apr 1.
PMID: 32239291DERIVEDNewgreen D, Bosman B, Hollestein-Havelaar A, Dahler E, Besuyen R, Sawyer W, Bolduc S, Rittig S. Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial. Eur Urol. 2017 Mar;71(3):483-490. doi: 10.1016/j.eururo.2016.08.061. Epub 2016 Sep 28.
PMID: 27687820DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Medical Science - Urology
- 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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
June 7, 2012
Primary Completion
December 31, 2013
Study Completion
January 2, 2014
Last Updated
October 31, 2024
Results First Posted
January 30, 2017
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/.