Study of ONO-8577 in Patients With Overactive Bladder
Phase 2
Completed
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT03106623
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-8577 Arm ONO-8577 Oral administration of ONO-8577 once a daily for 4 weeks Placebo Arm Placebo Oral administration of Placebo once a daily for 4 weeks Active Comparator Arm solifenacin succinate + mirabegron Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
- Primary Outcome Measures
Name Time Method Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours) Baseline and Week 4
- Secondary Outcome Measures
Name Time Method Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours) Baseline and Week 2 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 Volume Voided Per Micturition) Baseline, Week 2 and 4 Pharmacokinetics (plasma concentration at one point on each visit) Week 2 and 4 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 Nocturia Episodes Per 24 Hours) Baseline, Week 2 and 4 Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4 Week 2 and 4 Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) ) Baseline, Week 2 and 4 Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test) Up to Week 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 (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4) Week 2 and 4
Trial Locations
- Locations (30)
Gunma Clinical Site 02
🇯🇵Maebashi, Gunma, Japan
Gunma Clinical Site 01
🇯🇵Takasaki, Gunma, Japan
Hyogo Clinical Site 02
🇯🇵Akashi, Hyogo, Japan
Hyogo Clinical Site 01
🇯🇵Kobe, Hyogo, Japan
Hyogo Clinical Site 03
🇯🇵Kobe, Hyogo, Japan
Hyogo Clinical Site 04
🇯🇵Takarazuka, Hyogo, Japan
Kanagawa Clinical Site 01
🇯🇵Isehara, Kanagawa, Japan
Kanagawa Clinical Site 02
🇯🇵Kamakura, Kanagawa, Japan
Kanagawa Clinical Site 03
🇯🇵Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site 04
🇯🇵Yokohama, Kanagawa, Japan
Scroll for more (20 remaining)Gunma Clinical Site 02🇯🇵Maebashi, Gunma, Japan