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Completed

NCT Number: NCT00431041

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

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).

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mouth Diseases Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Signs and Symptoms Stomatognathic Diseases Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Calgary, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

solifenacin

Drug

Oral

Other names: VESIcare®, YM905

oxybutynin immediate release

Drug

Oral

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Canada, Inc.

Registry information

Official study title

VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients

Acronym: VECTOR

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 2, 2007
Registry last updated
Jun 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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