Overactive Bladder
Conditions
Brief summary
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
Interventions
DRUGONO-8577
Oral administration of ONO-8577 once a daily for 4 weeks
DRUGsolifenacin succinate + mirabegron
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
DRUGPlacebo
Oral administration of Placebo once a daily for 4 weeks
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours) | Baseline and Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test) | Up to Week 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 |
| 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 |
Countries
Japan
Outcome results
None listed