A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
NCT ID: NCT01981954
Last Updated: 2024-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2013-09-25
2015-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Solifenacin succinate
Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Solifenacin succinate
Oral suspension
Interventions
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Solifenacin succinate
Oral suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of NDO, confirmed by urodynamics
* DSD (detrusor sphincter dyssynergia)
* Practicing clean intermittent catheterization (CIC)
Exclusion Criteria
* Bladder augmentation surgery
* Current faecal impaction
* Electro-stimulation therapy within 2 weeks prior to visit
* Subjects with the following gastro-intestinal problems: partial or complete obstructions, decreased motility like paralytic ileus, subjects at risk of gastric retention
* Reflux grade 3 to 5
* Current urinary tract infection
6 Months
4 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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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site US1008 Pediatric Urology Associates, P.C.
Tarrytown, New York, United States
Site BE3203 Gent University Hospital
Ghent, , Belgium
Site PH6301 Philippines Children's Medical Center
Manila, , Philippines
Site PL4803 Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Site PL4801 Pomnik-Centrum Zdrowia Dziecka
Warsaw, , Poland
Site KR8207 Seoul National University Hospital
Seoul, , South Korea
Site KR8201 Severance Hospital
Seoul, , South Korea
Site GB4401 Sheffield Children's Hospital
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.
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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2012-003178-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-CL-074
Identifier Type: -
Identifier Source: org_study_id
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