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NCT01565707 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
A Phase 3 study, sponsored by Astellas Pharma Europe B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 189
- Enrollment target
NCT01565707: Completed Phase 3 study, sponsored by Astellas Pharma Europe B.V..
NCT01565707 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 189 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565707, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 189 participants
- Enrollment target
Study Summary
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
Primary Outcome
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.
Interventions
- DRUG Placebo
- DRUG Solifenacin Succinate Suspension
- BEHAVIORAL Urotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2012-06-07 |
| Est. Completion | 2014-01-02 |
| Phase | Phase 3 |
What the finished NCT01565707 record still lists
NCT01565707 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01565707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01565707 about?
NCT01565707 is a clinical study titled "A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug". Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin suc...
What is the current status of trial NCT01565707?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 189 participants. The study started on 2012-06-07. Estimated completion is 2014-01-02.
What interventions are being tested in trial NCT01565707?
The interventions under investigation include: Placebo (DRUG), Solifenacin Succinate Suspension (DRUG), Urotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01565707?
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 NCT01565707's enrollment target sits among peer trials
189 1408th of 2000 higher than 593 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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