Clinical trial NCT00662909: A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Official title: A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Frequency
YM178
Overactive bladder (OAB)
Micturition
Urgency
Urinary urge incontinence
Urinary incontinence
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 2149
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: The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder


Eligibility criteria: Inclusion Criteria:

* Patient is willing and able to complete the micturition diary and questionnaires correctly
* Patient has symptoms of overactive bladder for ≥ 3 months
* Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period

Exclusion Criteria:

* Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Patient receives non-drug treatment including electro-stimulation therapy
* Patient has severe hypertension
* Patient has a known or suspected hypersensitivity to YM178, other beta-adrenoreceptor (ß-AR) agonists, or any of the other inactive ingredients
* Patient has been treated with any investigational drug or device within 30 days
* Patient had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Patient has serum creatinine of \>150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or Gamma glutamyl transferase (γ-GT) \> 3x ULN
* Patient has a clinically significant abnormal electrocardiogram (ECG)

Primary outcomes:
measure: Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 12 (Final Visit)
measure: Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Weeks 8 and 12
measure: Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Weeks 8 and 12
measure: Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
timeFrame: Weeks 4, 8 and 12
measure: Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
timeFrame: Baseline and Week12
measure: Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
timeFrame: Baseline and Week 12
measure: Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Homewood
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Atherton
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Burbank
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Orange
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: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Torrance
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: New Britain
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Celebration
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Coeur d'Alene
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Melrose Park
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Jeffersonville
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Greenbelt
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: North Kansas City
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: West Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
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: Poughkeepsie
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Concord
country: United States
state: North Carolina
city: Wilmington
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: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Wadsworth
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Edmond
country: United States
state: Oklahoma
city: Bala-Cynwyd
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Mountlake Terrace
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Surrey
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: St Johns
country: Canada
state: New Brunswick
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Owen Sound
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Granby
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2013 Apr;189(4):1388-95. doi: 10.1016/j.juro.2012.10.017. Epub 2012 Oct 16.
citation: Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.