Clinical trial NCT00573508: Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Detailed description: Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.

The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.

Primary efficacy will be based on OAB-q symptom bother score.

Eligibility criteria: Inclusion Criteria:

* Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
* History of OAB symptoms for ≥ 3 months
* An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
* Subjects are bothered by symptoms as reflected by PPBC ≥3

Exclusion Criteria:

* Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
* Recurrent urinary tract infection (UTI) of \> 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
* History of diagnosed gastrointestinal obstruction disease
* Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
* Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics

Primary outcomes:
measure: Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and 12 Weeks
measure: Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Change From Baseline in Work Productivity Assessment Index (WPAI)
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in the MCUI Behavior Therapy Stratified
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Buena Park
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Fresno
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Melrose Park
country: United States
state: Illinois
city: Jeffersonville
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Watertown
country: United States
state: Massachusetts
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Englewood
country: United States
state: New Jersey
city: Lawrenceville
country: United States
state: New Jersey
city: Endwell
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Edmond
country: United States
state: Oklahoma
city: Central Point
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mount Lake
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
citation: Crosby RD, Mathias SD, Marshall TS. Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study. Int J Clin Pract. 2011 Feb;65(2):211-8. doi: 10.1111/j.1742-1241.2010.02532.x.