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

June 1, 2010 updated by: Astellas Pharma Inc

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4R6
      • Edmonton, Alberta, Canada, T5H 3V9
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
      • Victoria, British Columbia, Canada, V8T 5G1
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Guelph, Ontario, Canada, N1H 5J1
      • Kitchener, Ontario, Canada, N2N 2B9
      • Toronto, Ontario, Canada, M5T 2S8
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 1Z5
      • Toronto, Ontario, Canada, M6A 3B5
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solifenacin
Solifenacin succinate: 5 mg tablets, taken orally, once daily
Drug: solifenacin
Oral
Other Names:
  • YM905
  • VESIcare®
Active Comparator: Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
Drug: oxybutynin immediate release
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
Time Frame: 8 weeks
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
8 weeks
The Severity of Dry Mouth Reported as an Adverse Event
Time Frame: 8 weeks

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)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Time Frame: Baseline and 8 Weeks

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.
Baseline and 8 Weeks
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Time Frame: Baseline and 8 weeks

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.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Canada, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VES-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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