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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 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 189 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01565707
The ClinicalTrials.gov registry entry for NCT01565707 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Europe B.V., which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01565707 reports 0 study locations.
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.
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