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NCT01981954 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Astellas Pharma Europe B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT01981954: Completed Phase 3 study, sponsored by Astellas Pharma Europe B.V..
NCT01981954 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01981954, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.
Primary Outcome
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
Interventions
- DRUG Solifenacin succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2015-12-18 |
| Phase | Phase 3 |
What the finished NCT01981954 record still lists
NCT01981954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Solifenacin succinate is the first listed.
NCT01981954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01981954 about?
NCT01981954 is a clinical study titled "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)". The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.
What is the current status of trial NCT01981954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2013-09-25. Estimated completion is 2015-12-18.
What interventions are being tested in trial NCT01981954?
The interventions under investigation include: Solifenacin succinate (DRUG).
Who is sponsoring clinical trial NCT01981954?
This trial is sponsored by Astellas Pharma Europe B.V., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01981954's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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