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NCT01565694 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Astellas Pharma Europe B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 76
- Enrollment target
NCT01565694: Completed Phase 3 study, sponsored by Astellas Pharma Europe B.V..
NCT01565694 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 76 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565694, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 76 participants
- Enrollment target
Study Summary
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
Primary Outcome
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
Interventions
- DRUG Solifenacin succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2012-08-14 |
| Est. Completion | 2016-04-28 |
| Phase | Phase 3 |
What the finished NCT01565694 record still lists
NCT01565694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Solifenacin succinate is the first listed.
NCT01565694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01565694 about?
NCT01565694 is a clinical study titled "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". The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
What is the current status of trial NCT01565694?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 76 participants. The study started on 2012-08-14. Estimated completion is 2016-04-28.
What interventions are being tested in trial NCT01565694?
The interventions under investigation include: Solifenacin succinate (DRUG).
Who is sponsoring clinical trial NCT01565694?
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 NCT01565694's enrollment target sits among peer trials
76 1773rd of 2000 higher than 228 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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