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
NCT ID: NCT01565694
Last Updated: 2024-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2012-08-14
2016-04-28
Brief Summary
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Detailed Description
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The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.
Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Solifenacin succinate
Participants 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).
Solifenacin succinate
Oral suspension administered once a day via syringe.
Interventions
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Solifenacin succinate
Oral suspension administered once a day via syringe.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Practicing clean intermittent catheterization (CIC)
* Currently on treatment with an antimuscarinic drug
Exclusion Criteria
* 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
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 US1008
Tarrytown, New York, United States
Site US1010
Cincinnati, Ohio, United States
Site BE3201
Ghent, , Belgium
Site BR5505
São José do Rio Preto, São Paulo, Brazil
Site BR5507
Campinas, , Brazil
Site BR5504
Campinas, , Brazil
Site BR5506
Curitiba, , Brazil
Site BR5503
Porto Alegre, , Brazil
Site DK4501
Aarhus, , Denmark
Site HU3602
Miskolc, , Hungary
Site MX5203
León, , Mexico
Site MX5205
Mexico City, , Mexico
Site PH6301
Manila, , Philippines
Site PH6302
Quezon City, , Philippines
Site PL4803
Gdansk, , Poland
Site PL4805
Gdansk, , Poland
Site PL4801
Warsaw, , Poland
Site KR8207
Seoul, , South Korea
Site KR8201
Seoul, , South Korea
Site TR9003
Ankara, , Turkey (Türkiye)
Site TR9002
Izmir, , Turkey (Türkiye)
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.
Franco 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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2011-000330-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-CL-047
Identifier Type: -
Identifier Source: org_study_id
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