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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 is a Phase 4 study that has completed, run by Astellas Pharma. The registered enrollment target is 640 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG solifenacin succinate

Trial Details

FieldValue
Enrollment Target 640 participants
Start Date 2011-08-02
Est. Completion 2013-10-21
Phase Phase 4

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT01371994

The ClinicalTrials.gov registry entry for NCT01371994 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01371994 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.