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Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00431041
First received: February 1, 2007
Last updated: June 1, 2010
Last verified: June 2010
History of Changes

February 1, 2007
June 1, 2010
December 2006
February 2008   (final data collection date for primary outcome measure)
  • The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
  • The Severity of Dry Mouth Reported as an Adverse Event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

    The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).

    Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) & "severe" (very dry mouth & throat, difficulty swallowing solid food without water)
The primary objective is to evaluate the safety of solifenacin as compared to oxybutynin IR in patients with OAB symptoms
Complete list of historical versions of study NCT00431041 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]

    Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.

    The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline.

  • Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.

    The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline.
The secondary objective is to evaluate the efficacy of solifenacin and oxybutynin IR in an exploratory analysis in subjects with OAB symptoms as assessed by patient diary.
Not Provided
Not Provided
 
Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: solifenacin
    Oral
    Other Names:
    • VESIcare®
    • YM905
  • Drug: oxybutynin immediate release
    Oral
  • Experimental: Solifenacin
    Solifenacin succinate: 5 mg tablets, taken orally, once daily
    Intervention: Drug: solifenacin
  • Active Comparator: Oxybutynin IR
    Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
    Intervention: Drug: oxybutynin immediate release

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults 18 years and older.
  • Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Exclusion Criteria:

  • Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
  • Clinically significant outflow obstruction
  • Uncontrolled narrow angle glaucoma, urinary, or gastric retention
  • Severe renal or hepatic impairment
  • Chronic severe constipation or history of diagnosed GI obstructive disease
  • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Diagnosis or history of neurogenic bladder
  • History of bladder or pelvic cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00431041
VES-001
No
Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
Astellas Pharma Inc
June 2010

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