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
  Purpose

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).


Condition Intervention Phase
Overactive Bladder
Drug: solifenacin
Drug: oxybutynin immediate release
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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.



Enrollment: 132
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solifenacin
Solifenacin succinate: 5 mg tablets, taken orally, once daily
Drug: solifenacin
Oral
Other Names:
  • VESIcare®
  • YM905
Active Comparator: Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
Drug: oxybutynin immediate release
Oral

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431041

Locations
Canada, Alberta
Calgary, Alberta, Canada, T2V 4R6
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Victoria, British Columbia, Canada, V8T 5G1
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, 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
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00431041     History of Changes
Other Study ID Numbers: VES-001
Study First Received: February 1, 2007
Results First Received: October 5, 2009
Last Updated: June 1, 2010
Health Authority: Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Solifenacin succinate
Oxybutynin immediate release
Xerostomia
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Oxybutynin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014