Clinical TrialID 5338
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)
NCT01981954
Neurogenic Detrusor Overactivity|Pediatric
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5338
- Evidence Id
- 5338
- Core Evidence Id
- 5338
- Source Clinical Trial Id
- 5324
- Herb2 Clinical Trial Id
- HBCT005324
- Nct Id
- NCT01981954
- Title
- 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)
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Neurogenic Detrusor Overactivity|Pediatric
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Solifenacin succinate
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child
- Enrollment
- 23
- Outcome Measure
- Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC), MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity \[EBC\] was reached for participants ≥ 2 years or of maximum catheterized volume \[MCV\] for participants aged 6 months to \< 2 years; the participants' bladder was emptied via catheterization)., Baseline and Week 24
- Sponsor Collaborator
- Astellas Pharma Europe B.V.
- Funded By
- INDUSTRY
- Location
- Site US1008 Pediatric Urology Associates, P.C., Tarrytown, New York, 10591, United States|Site BE3203 Gent University Hospital, Gent, 9000, Belgium|Site KR8207 Seoul National University Hospital, Seoul, 110744, Korea, Republic of|Site KR8201 Severance Hospital, Seoul, 120752, Korea, Republic of|Site PH6301 Philippines Children's Medical Center, Manila, 1015, Philippines|Site PL4803 Uniwersyteckie Centrum Kliniczne, Gdansk, 81-211, Poland|Site PL4801 Pomnik-Centrum Zdrowia Dziecka, Warszawa, 04-730, Poland|Site GB4401 Sheffield Children's Hospital, Sheffield, S10 2TN, United Kingdom
- Other Id
- 905-CL-074|2012-003178-22
- Start Date
- 2013-09-25
- Primary Completion Date
- 2015-12-18
- Completion Date
- 2015-12-18
- First Posted
- 2013-11-13
- Results First Posted
- 2018-06-21
- Last Update Posted
- 2018-11-16
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01981954
- Title Cn
- Title En
- 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)
- Bilingual Status
- semi_complete