Clinical trial NCT00912964: A Study to Test the 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 the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects With Symptoms of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Urgency
YM178
Urinary incontinence
Mirabegron
Micturition
Frequency
Urinary urgency incontinence
Overactive Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 2030
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 efficacy, safety and tolerability of two doses of once daily (qd) 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 (OAB) 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 is using medications intended to treat OAB
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient has evidence of 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 participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
* 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 transpeptidase (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
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 End of Treatment (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 End of Treatment (Final Visit) in Mean Level of Urgency
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
timeFrame: Baseline and Week 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 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 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 and Week 12 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 and Week 12 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 and Week 12 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: Percentage of Responders for Mean Level of Urgency
timeFrame: Baseline and Week 12
measure: Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes
timeFrame: Baseline and Week 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 Week 12
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 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
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: Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale
timeFrame: Baseline and Week 12
measure: Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale
timeFrame: Baseline and Week 12
measure: Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale
timeFrame: Baseline and Week 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
Other outcomes:
Locations:
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state: Georgia
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city: Winnipeg
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state: New Brunswick
city: Saint John
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city: Barrie
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state: Ontario
city: Brampton
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city: Brantford
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city: Kitchener
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city: North Bay
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city: Thunder Bay
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city: Toronto
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city: Granby
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state: Quebec
city: Sherbrooke
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state: Quebec
city: Olomouc
country: Czechia
city: Ostrava
country: Czechia
city: Prague 4
country: Czechia
city: Prague
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city: Prague
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city: Aalborg
country: Denmark
city: Aarhus N
country: Denmark
city: Frederiksberg
country: Denmark
city: Holstebro
country: Denmark
city: Helsinki
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Bad Ems
country: Germany
city: Frankfurt
country: Germany
city: Hagenow
country: Germany
city: Halle / Saale
country: Germany
city: Henningsdorf
country: Germany
city: Hettstedt
country: Germany
city: Koblenz
country: Germany
city: Leipzig
country: Germany
city: Lutherstadt Eisleben
country: Germany
city: Neunkirchen
country: Germany
city: Neustadt in Sachsen
country: Germany
city: Radebeul
country: Germany
city: Sangerhausen
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kormend
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Sopron
country: Hungary
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country: Hungary
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country: Hungary
city: Szentes
country: Hungary
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country: Hungary
city: Bergen
country: Norway
city: Hamar
country: Norway
city: Tonsberg
country: Norway
city: Martin
country: Slovakia
city: Trencin
country: Slovakia
city: Zilina
country: Slovakia
city: Barcelona
country: Spain
city: Coslada
country: Spain
city: Getafe Madrid
country: Spain
city: Gran Canaria
country: Spain
city: Madrid
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city: Madrid
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city: Vic
country: Spain
city: Gothenburg
country: Sweden
city: Huddinge
country: Sweden
city: Jonkoping
country: Sweden
city: Karlshamn
country: Sweden
city: Malmo
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
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.
citation: Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.