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NCT01371994 · ClinicalTrials.gov registry record · Phase 4
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
A Phase 4 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 640
- Enrollment target
NCT01371994: Completed Phase 4 study, sponsored by Astellas Pharma.
NCT01371994 is a Phase 4 study that has completed, run by Astellas Pharma. The registered enrollment target is 640 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01371994, a Phase 4 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 640 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy. This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.
Primary Outcome
Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period w
Interventions
- DRUG Placebo
- DRUG solifenacin succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2011-08-02 |
| Est. Completion | 2013-10-21 |
| Phase | Phase 4 |
What the finished NCT01371994 record still lists
NCT01371994 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01371994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01371994 about?
NCT01371994 is a clinical study titled "A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy". The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy. This study will also assess the effect of 12 weeks of treatment with solifenacin succinat...
What is the current status of trial NCT01371994?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 640 participants. The study started on 2011-08-02. Estimated completion is 2013-10-21.
What interventions are being tested in trial NCT01371994?
The interventions under investigation include: Placebo (DRUG), solifenacin succinate (DRUG).
Who is sponsoring clinical trial NCT01371994?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01371994's enrollment target sits among peer trials
640 127th of 2000 higher than 1,874 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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