A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Overactive Bladder (OAB)
- Sponsor
- Astellas Pharma Global Development, Inc.
- Enrollment
- 888
- Locations
- 120
- Primary Endpoint
- Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
Intervention: Placebo
Mirabegron
Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
Intervention: Mirabegron
Outcomes
Primary Outcomes
Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and EOT (up to 12 weeks)
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame: Baseline and EOT (up to 12 weeks)
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.
Secondary Outcomes
- Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Mean Volume Voided Per Micturition(Baseline and EOT (up to 12 weeks))
- Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Barthel Index of Daily Living Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and EOT (up to 12 weeks))
- Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours(End of treatment (up to 12 weeks))
- Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC(End of treatment (up to 12 weeks))
- Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in PPIUS(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)(Baseline and EOT (up to 12 weeks))
- Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit(Baseline and Weeks 4, 8 and EOT (up to 12 weeks))
- Percentage of Participants With Zero Incontinence Episodes Per 24 Hours(End of treatment (up to 12 weeks))
- Change From Baseline to EOT in OAB-q HRQL Subscale Scores(Baseline and EOT (up to 12 weeks))
- Percentage of Participants Who Achieved Micturition Frequency Normalization(End of treatment (up to 12 weeks))
- Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline in Post-void Residual Volume (PVR)(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)(Baseline and EOT (up to 12 weeks))
- Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales(End of treatment (up to 12 weeks))
- Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC(End of treatment (up to 12 weeks))
- Number of Participants With Adverse Events (AEs)(From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks))