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

Official Title: “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).

Intervention(s) in this Clinical Trial

• Drug: solifenacin
  • Oral
• Drug: oxybutynin immediate release
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Solifenacin
  • Solifenacin succinate: 5 mg tablets, taken orally, once daily
• Active Comparator: Oxybutynin IR
  • Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day

Primary Measures

• The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• The Severity of Dry Mouth Reported as an Adverse Event
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Secondary Measures

• Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
  • Time Frame: Baseline and 8 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Astellas Pharma Canada, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00431041

Study ID Number: VES-001

ClinicalTrials.gov Identifier: NCT00431041

Health Authority: Canada: Health Canada

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