Study of ONO-8577 in Patients With Overactive Bladder

Study Overview
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Brief Summary
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The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for overactive bladder

Official Title
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Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: ONO-8577
* Drug: solifenacin succinate + mirabegron
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with symptoms of overactive bladder for ≥6 months Exclusion Criteria: Patient with genuine stress incontinence, or with stress-predominant mixed urinary incontinence Patient who has never experienced urge urinary incontinence during disease duration of overactive bladder

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-8577 Arm<br>Oral administration of ONO-8577 once a daily for 4 weeks | Drug: ONO-8577<br>* Oral administration of ONO-8577 once a daily for 4 weeks<br>|
| Active Comparator: Active Comparator Arm<br>Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks | Drug: solifenacin succinate + mirabegron<br>* Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks<br>|
| Placebo Comparator: Placebo Arm<br>Oral administration of Placebo once a daily for 4 weeks | Drug: Placebo<br>* Oral administration of Placebo once a daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours) |  | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test) |  | Up to Week 4 | 
| Pharmacokinetics (plasma concentration at one point on each visit) |  | Week 2 and 4 | 
| Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours) |  | Baseline and Week 2 | 
| Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours) |  | Baseline, Week 2 and 4 | 
| Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours) |  | Baseline, Week 2 and 4 | 
| Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours) |  | Baseline, Week 2 and 4 | 
| Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours) |  | Baseline, Week 2 and 4 | 
| Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours) |  | Baseline, Week 2 and 4 | 
| Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4) |  | Week 2 and 4 | 
| Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4 |  | Week 2 and 4 | 
| Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition) |  | Baseline, Week 2 and 4 | 
| Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) ) |  | Baseline, Week 2 and 4 | 
| Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life) |  | Baseline and Week 4 | 
| Efficacy (Patient Global Impression at Week 4) |  | Week 4 |