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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
solifenacin
oxybutynin immediate release
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Solifenacin succinate, Oxybutynin immediate release, Xerostomia, Overactive bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Solifenacin

Oxybutynin IR

Arm Description

Solifenacin succinate: 5 mg tablets, taken orally, once daily

Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day

Outcomes

Primary Outcome Measures

The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
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
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)

Secondary Outcome Measures

Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
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
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.

Full Information

First Posted
February 1, 2007
Last Updated
June 1, 2010
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Canada, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00431041
Brief Title
Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Canada, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Solifenacin succinate, Oxybutynin immediate release, Xerostomia, Overactive bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin
Arm Type
Experimental
Arm Description
Solifenacin succinate: 5 mg tablets, taken orally, once daily
Arm Title
Oxybutynin IR
Arm Type
Active Comparator
Arm Description
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
VESIcare®, YM905
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
oxybutynin immediate release
Intervention Description
Oral
Primary Outcome Measure Information:
Title
The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
Description
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
Time Frame
8 weeks
Title
The Severity of Dry Mouth Reported as an Adverse Event
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Description
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.
Time Frame
Baseline and 8 Weeks
Title
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Description
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.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Canada, Inc.
Official's Role
Study Director
Facility Information:
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4R6
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 5J1
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20303119
Citation
Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29.
Results Reference
background
PubMed Identifier
21175373
Citation
Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23.
Results Reference
derived
PubMed Identifier
20690893
Citation
Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244.
Results Reference
derived

Learn more about this trial

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

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