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
NCT ID: NCT01565707
Last Updated: 2024-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2012-06-07
2014-01-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Children
Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
Placebo
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.
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.
Solifenacin Succinate Suspension Children
Children 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.
Solifenacin Succinate Suspension
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.
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.
Placebo Adolescents
Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
Placebo
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.
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.
Solifenacin Succinate Suspension Adolescents
Adolescents 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.
Solifenacin Succinate Suspension
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.
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.
Interventions
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Solifenacin Succinate Suspension
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.
Placebo
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
5 Years
17 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Site: 1006
Shreveport, Louisiana, United States
Site: 1015
Albany, New York, United States
Site: 3202
Antwerp, , Belgium
Site: 3209
Antwerp, , Belgium
Site: 3208
Charleroi, , Belgium
Site: 3201
Ghent, , Belgium
Site: 3203
Ghent, , Belgium
Site: 3204
Kortrijk, , Belgium
Site: 3205
Leuven, , Belgium
Site: 5507
Campinas, , Brazil
Site: 5506
Curitiba, , Brazil
Site: 1005
Hamilton, , Canada
Site: 1001
Québec, , Canada
Site: 4503
Aalborg, , Denmark
Site: 4501
Aarhus N, , Denmark
Site: 4502
Kolding, , Denmark
Site: 4504
Køge, , Denmark
Site: 5202
Mexico City, , Mexico
Site: 5205
Mexico City, , Mexico
Site: 4701
Bergen, , Norway
Site: 4702
Trondheim, , Norway
Site: 6301
Quezon City, , Philippines
Site: 4805
Gdansk, , Poland
Site: 4803
Gdansk, , Poland
Site: 4804
Lubin, , Poland
Site: 4801
Warsaw, , Poland
Site: 3810
Belgrade, , Serbia and Montenegro
Site: 3812
Novi Sad, , Serbia and Montenegro
Site: 2703
Cape Town, , South Africa
Site:8203
Daegu, , South Korea
Site: 8206
Incheon, , South Korea
Site: 8207
Seoul, , South Korea
Site: 8201
Seoul, , South Korea
Site:8202
Seoul, , South Korea
Site: 4606
Gothenburg, , Sweden
Site: 4601
Jönköping, , Sweden
Site: 4603
Skövde, , Sweden
Site: 4602
Stockholm, , Sweden
Site: 4605
Umeå, , Sweden
Site: 9001
Ankara, , Turkey (Türkiye)
Site: 9002
Izmir, , Turkey (Türkiye)
Site: 3853
Dnipropetrovsk, , Ukraine
Site: 3854
Kharkiv, , Ukraine
Site: 3850
Kiev, , Ukraine
Site: 4403
Leeds, , United Kingdom
Site: 4401
Sheffield, , United Kingdom
Countries
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References
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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.
Snijder 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.
Newgreen 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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2011-002066-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-CL-076
Identifier Type: -
Identifier Source: org_study_id
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