A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in Subjects After Robotic Assisted Radical Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01371994
First received: June 10, 2011
Last updated: November 11, 2013
Last verified: November 2013

June 10, 2011
November 11, 2013
August 2011
October 2013   (final data collection date for primary outcome measure)
The time from the date of first dose to the date of urinary continence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Urinary continence will be defined as the first of three consecutive 24 hour days which subject uses 0 pads, or a pad for security which remains completely dry, during the 12 week study
Same as current
Complete list of historical versions of study NCT01371994 on ClinicalTrials.gov Archive Site
  • Proportion of subjects who gain urinary continence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to each month in average daily pad usage [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life (QOL) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    QOL as measured by the American Urology Association Symptom Score (AUASS)
  • Change from baseline in quality of life (QOL) [ Time Frame: Bsaeleine and 12 weeks ] [ Designated as safety issue: No ]
    QOL as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
  • Change from baseline to end of study on work productivity [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Work productivity will be measured by the Work Productivity and Activity Impairment Questionnaire (WPAI)
  • Time from baseline to first day of returning to work [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in Subjects After Robotic Assisted Radical Prostatectomy
A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of VESIcare® versus placebo in subjects who are incontinent after Robotic Assisted Radical Prostatectomy.

This study will also assess the effect of 12 weeks of treatment with VESIcare versus placebo on quality of life (QOL) as measured by questionnaires.

The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.

Subjects will complete an electronic daily pad use diary during the study duration. Subjects will also be asked to complete several questionnaires during the study.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: solifenacin succinate
    oral
    Other Names:
    • Vesicare
    • YM905
  • Drug: Placebo
    oral
  • Experimental: solifenacin succinate
    Intervention: Drug: solifenacin succinate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
629
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is ambulatory
  • Subject is willing and able to complete the daily pad use diary, American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)
  • Subject has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
  • Subject has been diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days

Exclusion Criteria:

  • Subject has evidence of severe neurologic damage post-prostatectomy
  • Subject has evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
  • Subject is symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.
  • Subject has a clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in ALT, AST or creatinine clearance < 30 ml/min)
  • Subject has history of diagnosed gastrointestinal obstruction disease
  • Subject has any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct
  • Subject has known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
  • Subject has been treated with any investigational drug within last 30 days
  • Subject has a history of a clinically significant illness or medical condition that would preclude participation in the study
  • Subject has been diagnosed with New York Heart Association Class III and IV heart failure
  • Subject has the following peri-operative laboratory results: ALT > 2.0 ULN, AST > 2.0 ULN, serum creatinine > 1.5 mg/L, blood glucose > 130 mg/dL, BUN > 23 mg/dL.
  • Subject has severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, and which is not corrected
  • Subject has electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Subject can be eligible if electrolytes are corrected to within normal range prior to randomization
  • Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01371994
905-UC-050
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP